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Table of Contents
GUIDELINE AND CONSENSUS
Year : 2018  |  Volume : 3  |  Issue : 3  |  Page : 108-113

Transcatheter aortic valve replacement: Team construction and operation specifications recommended by Chinese experts


Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai Institute of Cardiovascular Diseases, Shanghai, China

Date of Web Publication24-Sep-2018

Correspondence Address:
Junbo Ge
Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai Institute of Cardiovascular Diseases, Shanghai
China
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/cp.cp_29_18

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How to cite this article:
Ge J. Transcatheter aortic valve replacement: Team construction and operation specifications recommended by Chinese experts. Cardiol Plus 2018;3:108-13

How to cite this URL:
Ge J. Transcatheter aortic valve replacement: Team construction and operation specifications recommended by Chinese experts. Cardiol Plus [serial online] 2018 [cited 2018 Oct 19];3:108-13. Available from: http://www.cardiologyplus.org/text.asp?2018/3/3/108/242083




  Introduction Top


Transcatheter aortic valve replacement (TAVR) refers to the replacement of an aortic valve by placing an assembled aortic valve into a diseased aortic valve through a catheter. TAVR is a revolutionary technique for the treatment of aortic valve stenosis. Currently, European and American guidelines recommend patients with high or moderate risk of aortic stenosis for TAVR.[1],[2],[3] TAVR is a complex, high-risk technology, which requires the cooperation of many disciplines, such as departments of cardiology, cardiac surgery, imaging, and anesthesiology, so it is necessary to establish a multidisciplinary heart team.

The domestic TAVR was approved for sale in China in May 2017, and TAVR will be widely promoted in China. In order to promote the standardization, safety, and smooth promotion of TAVR in China, this proposal was organized by the structural cardiology group of the Chinese Medical Doctor Association Department of cardiovascular physicians, the Chinese Medical Doctor Association, the Chinese Medical Association for cardiovascular diseases, and the structural cardiology group. This recommendation is primarily written for TAVR via the peripheral vascular pathways.

Background

TAVR is becoming a more secure and mature technology. Recently, TAVR has been performed with a “minimalist approach,”[4],[5] and the recognition of the TAVR team is gradually weakening. However, under current medical guidelines in China, it is still necessary to prioritize the implementation of a TAVR team for several reasons. First, although TAVR is growing into a safe and standard procedure, it is still a high-risk and complex surgery compared to traditional interventional procedures. Even in the latest clinical trials, the perioperative mortality of TAVR is still 2%–4%, and the incidence of permanent pacemaker implantation, paravalvular leak, and vascular complications is still relatively high.[6],[7] Second, the domestic valve currently listed in China is the first-generation valve, which does not have the function of recycling, relocating, and preventing leakage. There is a high proportion of two-leaf valves and serious calcification in Chinese TAVR patients.[8],[9] Therefore, there is a high risk in performing TAVR in China at present. Third, TAVR is a complex technology, its classical development methods require coordination among multidisciplinary personnel such as cardiology, cardiac surgery, imaging, and anesthesiology.[10] Finally, TAVR has an steep learning curve,[11] and TAVR is more successful when conducting system-based training and team-standardized operations. In order to promote the standardization, safety, and smooth promotion of TAVR in China, it is suggested that the multidisciplinary heart team (MDHT) of TAVR should be established in China to train the team personnel systematically and to promote adherence to the corresponding technical specifications.

Team composition and personnel requirements

Referring to the international guide,[12] it is recommended that the MDHT of TAVR consists of interventional physicians, cardiovascular surgeons (cardiologists), echocardiogram physicians, radiologists, anesthesiologists, nurses, and related professional and technical personnel, and the team must undergo systematic training. TAVR team members are required to include the following:[13]

  1. Interventional physicians: The TAVR interventional physicians are the core of the MDHT team. They should comprise 3–4 members, have managerial experience, hold the title of deputy chief physician, and all members should have experience in interventional therapy for cardiovascular disease. They are the main decision makers of the preoperative assessment, the operators of the TAVR surgery, and responsible for postoperative follow-up. The lead interventional physician should handle more than 200 cases per year and have received systematic training. Other assistant doctors should have the qualifications of an attending physician or above and have experience in independent intervention. The lead interventional physician should be able to independently analyze the patient's imaging data, especially the multiple-slice spiral computed tomography (MSCT), to determine whether the patient is suitable for the operation and to select the approach and valve model. The first twenty cases of TAVR should be completed under the guidance of experienced surgeons, and then TAVR may be carried out independently
  2. Cardiac surgeon: A cardiac surgeon, who is the deputy director of the doctor, is required to perform more than fifty cases of heart valve surgery in 1 year before they are suitable for a TAVR team
  3. Radiologist: A senior doctor who is above the title senior of doctor, familiar with MSCT, and has completed the scanning and analysis of MSCT
  4. Anesthesiologists: An anesthesiologist with at least 3 years of experience in cardiovascular anesthesia and at least one assistant who has completed TAVR anesthesia
  5. Echocardiographer: One echocardiographer with >5 years of experience in echocardiographic work, >1 year experience in transesophageal echocardiography, and at least one assistant to complete the preoperative, intraoperative, and postoperative echocardiographic examinations of TAVR
  6. Nursing staff: The nursing team members are generally served by specialist nurses, who are divided into ward specialist nurses, catheter room nurses, and coronary care unit (CCU) nurses. At least one nurse should have >3 years of working experience
  7. Others: The center for TAVR must have a cardiac surgeon with the ability to deal with vascular complications. If necessary, the intensive care unit (ICU), respiratory department, and geriatrics should be involved.


Team responsibilities

  1. Preoperative screening and evaluation is completed by the MDHT, including the following: (a) The intervention physicians evaluate the preoperative condition of the patients as a whole, assess whether a TAVR is needed, whether they could benefit from the operation, and whether their anatomy is suitable for TAVR. (b) The cardiac surgeons assess the risk of cardiac surgery and whether a surgical assistance approach is needed, the approach is appropriate, and make a remedial surgical plan available. (c) The echocardiographer evaluates cardiac function, valve conditions, and aortic root anatomy. (d) The radiologist assesses whether the patient's anatomy is suitable for TAVR and coronary artery lesions. (e) The anesthesiologists assess the risk of anesthesia for surgery. It is recommended that members of the TAVR team members determine whether the patient is suitable for TAVR through open discussion
  2. Intraoperative Collaboration: During the operation, the team members must be at the scene, perform their duties, and work closely together. The intervention physicians are responsible for the operation, and other relevant personnel of the various departments should be well coordinated. For example, the nurse prepares the apparatus, the anesthesiologist performs and closely monitors anesthesia, and the echocardiographer performs ultrasound monitoring if necessary. The radiologist should adjust the digital subtraction angiography and assist the angiography. Professionally trained personnel loads the valve and the cardiac surgeon assists in the treatment of the approach and can perform the operation at any time
  3. Perioperative management: In anticipation of the patient's possible postoperative complications and hemodynamic abnormalities, it is recommended that the patient be managed by a trained specialist after the operation. Intensive care can be carried out in CCU or ICU or specialized TAVR ward units, and the ward should be closely monitored and managed by the ward's competent physician and nurse. Surgeons should explain the relevant precautions. For particularly critical patients, it is necessary to maintain an increased frequency of observation until the patient's condition is stable. The anesthesiologist should perform a postoperative inspection. If the patient's perioperative condition changes or complications occur during this period, either the doctors in charge of the ward or a surgeon should organize corresponding experts to formulate a rescue strategy for rescue
  4. Postoperative follow-up: The interventional physician is primarily responsible for the postoperative follow-up, while the radiologist and echocardiographer assist in completing the relevant examinations
  5. Summary and improvement: Team members should regularly organize discussions and summarize the experience of completing cases and continuously improve technical points, implementation plans, and operation processes.


Team specifications

Interventional physician

  1. Preoperative assessment and screening: This includes clinical factors and imaging evaluation. Clinical assessment includes: (a) whether valve replacement is required; (b) surgical risk assessment;[13] (c) TAVR contraindications. Imaging evaluation is mainly to assess whether the patient's anatomy is suitable for TAVR. It is recommended that the head physician analyze the imaging data of the patient (MSCT) to determine whether the patient is suitable for surgery and to select a valve model
  2. Intraoperative: The interventional physician is the main operator of TAVR, and the main points of operation refer to the “Chinese expert consensus on Transcatheter Aortic Valve Replacement”[13]
  3. Perioperative management: Patients may be managed by the CCU or other nonsurgeons after surgery, but the interventional physician still needs to play a major role in postoperative management. The relevant doctors should be informed of the surgical situation, complications, and precautions, and relevant treatment strategies should be formulated. Patients should be visited frequently, especially in critical cases. If conditions permit, it is recommended to set up postoperative TAVR ward to manage patients after the surgery
  4. Postoperative follow-up: It is recommended that doctors follow up with the patients at 1, 3, 6, and 12 months after the operation, and once a year routinely thereafter. The follow-up contents include the position and function of the prosthetic valve, the heart function, and the complications. The examination items mainly include echocardiography, electrocardiogram (ECG), and other items including brain natriuretic peptide, and blood routine.


Cardiac surgeon

  1. Preoperative assessment and screening: Assessment should be made according to the Society of Thoracic Surgeons scoring system, the European System for Cardiac Operative Risk Evaluation score, Weakness Index, the possibility of major organ damage that cannot be improved by surgery, related surgical operation disorders, etc.[2] These factors should be combined with the operation experience of the cardiac center and comprehensively evaluate the surgical risk of patients. When a surgical approach is required, assess the feasibility and safety of the associated approach
  2. Intraoperative collaboration and postoperative management: Assist in the treatment of related approaches. For emergent surgical operations, remedial surgery is performed after detailed discussion with the interventional physician.


Radiologists

Imaging evaluation by radiologists is the focus of preoperative assessment and screening of TAVR, of which MSCT is particularly important.

  1. MSCT scan technique requires:[14] (i) recommended thickness: ≤1 mm; (ii) ECG gating, taking the end of systolic period (about 40% of the cardiac cycle); (iii) an enhanced computed tomography (CT) scan (injection contrast); (iv) imaging the body from below the neck down to the knee joint, to assess all available peripheral vascular access (femoral artery, subosseous artery, etc.). For patients with aortic stenosis, β-blockers and nitrates should be avoided to prevent hemodynamic complications during examination Aortic root scanning must be done with ECG gating techniques (retrospective or prospective) and a high-pitch scan. The abdominal aorta and iliac femoral artery do not require ECG gating and high-pitch scanning, which can significantly reduce the radiation dose and the dosage of contrast medium
  2. MSCT analysis includes:[14] (i) the circumference, area, and diameter of aortic annulus as the main reference for TAVR valve selection; (ii) aortic root anatomy, including coronary artery height, aortic sinus width, ascending aorta width, sinus tube junction, and left ventricular outflow tract; (iii) aortic valve morphology, judged to be two leaf or three lobed, analysis of leaflet thickness, fusion, and calcification (including calcification, distribution, and continuity). The leaflet morphology can also serve as a reference for selection of TAVR valves. (iv) assessment of the vascular approach, including the femoral artery, subclavian artery, carotid artery, ascending aorta, and transapical approach to understand the internal diameter, distortion, and calcification of the approach; (v) coronary artery lesions; (vi) MSCT assists in determining the best angiographic angle of the operation. In addition, intraoperative radiologists should assist in the adjustment of the patient's head for digital subtraction angiography and completing the angiography.


Anesthesiologist

The anesthesiologist is responsible for:

  1. Preoperative assessment: The anesthesiologist should check the patient before the operation. By reviewing the patient's medical history, physical examination, laboratory examination, and imaging results, they can comprehensively understand the general situation of the patient, the history of noncardiac disease, and cognitive ability to assess the anesthesia risk. They should ask about medication history and allergy history and make a routine airway assessment. Preoperative medication can help patients to relieve anxiety before induction of anesthesia and also help avoid adverse cardiac events due to tachycardia
  2. Intraoperative collaboration: For patients with TAVR, anesthesiologists should open at least one unobstructed venous access (recommended central venous catheter) and monitor invasive blood pressure. The necessary monitoring items during the operation include ECG, finger oxygen saturation, body temperature, end-tidal carbon dioxide partial pressure, central venous pressure, and active clotting time


  3. In order to correct any possible arrhythmia, the electrode sheets of external cardioversion should be placed and connected before anesthesia induction. At the beginning of the TAVR operation, general anesthesia (single-lumen endotracheal intubation) is generally recommended. Anesthesia induction should be slow and stable, and the sinus rhythm should be maintained as far as possible during anesthesia management

    Be careful to maintain adequate preload and avoid using vasodilator drugs to ensure ventricular filling pressure. Norepinephrine or phenylephrine can be used in small doses to maintain systemic resistance, avoid hypotension, and ensure adequate perfusion of the hypertrophic myocardium. To prevent tachycardia, anesthesiologists will also need to avoid severe bradycardia. Possible intravenous anesthetics are etomidate, propofol, ketamine, and opioids such as fentanyl, sufentanil, remifentanil (small dose of intravenous infusion), and possible inhaled anesthetics are sevoflurane, desflurane, muscle relaxants such as rocuronium, and cisatracurium. On the one hand, it is considered that patients with TAVR are generally older. On the other hand, if the tracheal catheter is removed after surgery, benzodiazepines are not recommended. If inhalation anesthetics are selected, attention should be given to controlling the concentration of drug inhalation and avoiding excessive inhibition of myocardium

    In an experienced TAVR center, the operation can also be performed with a local anesthesia combined with sedation. Local anesthetic sedative prohibition is used in the following situations: severe sleep apnea, predicting poor airway, patients cannot be supine, severe gastroesophageal reflux, mental disorders or communication disorders, or the transesophageal echocardiography must be used during surgery. The sedative drug generally chosen is dexmedetomidine for continuous intravenous infusion. Small doses of opioids can be added to the femoral artery sheath. Before the balloon dilation, propofol is given as needed, with no inhibition of breathing as a criterion. During the operation, the bispectral index can be monitored and maintained at 65–75. The patient's respiratory and circulatory conditions must be closely monitored throughout the procedure and general anesthesia must be prepared as a standby. If there are complications, change to general anesthesia immediately. If a patient has an upper respiratory tract obstruction such as a tongue falling, try to wake up or open the oropharyngeal airway. If the chest wall stiffness or pulse oxygen saturation noticeably drops, try mask ventilation. If there is no noticeable improvement, the operation should be immediately switched to using general anesthesia

  4. Postoperative monitoring: If the operation is performed under general anesthesia, early extubation is recommended. It is suggested that patients be sent to the ICU for postoperative care, monitoring and recording patient's postoperative recovery, including vital signs, cognitive function, volume, and bleeding. The recovery of cardiac function should be evaluated continuously, the healing of the surgical incision is closely observed, and the formation of hemorrhage, hematoma, pseudoaneurysm, and thromboembolism should be caught quickly. Proper individualized analgesia can help patients recover more quickly.


Echocardiographer

  1. Preoperative assessment: To determine whether the aortic valve is severely stenotic: Measuring the left ventricular outflow tract diameter, the peak and mean pressure difference across the aortic valve is measured by continuous Doppler and the left ventricular outflow tract is measured by pulsed Doppler. Flow time integration, the aortic valve area is calculated according to the continuity equation method


  2. The anatomical structure of the left ventricular outflow tract, aortic ring, aortic root, the junction of the trunk of the sinus, the ascending aorta, and the aortic valve are evaluated for TAVR. The patient's valvular condition, left ventricular function, pulmonary hypertension, and pericardial effusion are assessed. For patients with partial left ventricular dysfunction, perform the dobutamine test if the peak value and mean pressure difference across the aortic valves do not reach the severe standard

  3. Intraoperative assessment: (i) Evaluating the degree of reflux of the aortic valve and stenosis of the aortic valve after balloon dilation; (ii) The position of artificial aortic valve should be checked immediately after implantation of artificial aortic valve and its function evaluated, including valve reflux and paravalvular leakage, mean pressure difference of artificial aortic valve, and valvular area. (iii) Rapid monitoring of various complications: Determine the cardiac tamponade caused by the guidewire penetrating the left and right ventricles, left ventricular failure, or severe primary arterial regurgitation; a possible cause of sudden increase in mitral regurgitation during surgery, especially the guidewire wrapped around the mitral chordae


  4. Postoperative follow-up: Evaluation of the area of artificial aortic valve flap; accurate quantitative artificial aortic valve reflux and measurement of paravalvular leakage; evaluation of other valve conditions and the size and function of the heart.


Nursing staff

  1. Preoperative evaluation and nursing: Complete routine tests, blood grouping, blood preparation, and related examinations according to doctor's advice before surgery. The purpose, method, and precautions of the operation should be presented to the patient to relieve nervousness and achieve cooperation. Prepare the skin on the day of the operation. Follow strict fasting and water ban. Follow the doctor's advice to catheterize and establish a venous access. Preoperative medication should be given according to the anesthesiologist, and the patient should be closely observed for adverse reactions. The nurses in the catheter room should prepare the TAVR instruments before operation
  2. Intraoperative collaboration: During the operation: Prepare the operating table, assist with disinfection, tissue, and catheterization, attach the electrodes and defibrillation patches, connect the hemodynamic and ECG monitoring equipment, and dismantle the relevant surgical instruments. Check the instruments 1 day before operation to improve the accuracy of the instruments
  3. Postoperative care: There should be a comprehensive understanding of the patient's surgical situation and any abnormalities during the operation, cooperate with the doctor for the appropriate treatment. Postoperative general anesthesia care: Closely monitor the patient's vital signs, consciousness, and blood oxygen saturation until they are stable and recorded. Observe ECG, basic physiological reflex, and perception of patients.


Follow the doctor's advice to fast, ban water for 2–4 h, then start a small amount of liquid diet, no cough, and give a semi-liquid diet. Observe the wound condition, skin temperature, skin color, and arterial pulse condition. Follow the doctor's instructions to brake the lower limbs and move the toe to prevent thrombosis. Do the related catheter care: Endotracheal intubation, temporary pacemaker, deep venous catheter, catheter, and invasive arterial blood pressure catheter. Observe whether there are the following complications: arrhythmia, cerebral infarction, puncture-site bleeding, paravalvular leakage, cardiac tamponade, or myocardial infarction. Patients should be encouraged to get out of bed early to prevent thrombosis.

Other personnel

Other personnel include cardiac surgeons who can deal with vascular complications and others such as neurology, respiratory physician, and geriatric staff. These personnel must be fixed, trained to familiarize with, or understand the clinical problems related to TAVR. Although these people are not necessary for a regular TAVR team, they can work together with the TAVR team to deal with related issues when required, such as preoperative assessment and complication handling.

Note: This article is published in the Chinese Journal of interventional cardiology in Chinese simultaneously.

Members of the writing group

Daxin Zhou (Zhongshan Hospital Affiliated to Fudan University, Shanghai); Wenzhi Pan (Zhongshan Hospital Affiliated to Fudan University, Shanghai); Kefang Guo (Zhongshan Hospital Affiliated to Fudan University, Shanghai); Cuizhen Pan (Zhongshan Hospital Affiliated to Fudan University, Shanghai); Xue Yang (Zhongshan Hospital Affiliated to Fudan University, Shanghai); Yongjian Wu (Fuwai Hospital, Beijing); Xiangqing Kong (The First Affiliated Hospital of Nanjing Medical University, Nanjing); Xianying Liu (The Second Affiliated Hospital of Medical College of Zhejiang University, Hangzhou); Junbo Ge (Zhongshan Hospital Affiliated to Fudan University, Shanghai)

Panelists (in alphabetical order by surname)

Bo Yu (The Second Affiliated Hospital of Harbin Medical University, Harbin); Cuizhen Pan (Zhongshan Hospital Affiliated to Fudan University, Shanghai); Daxin Zhou (Zhongshan Hospital Affiliated to Fudan University, Shanghai); Gejun Zhang (Fuwai Hospital, Beijing); Guangwei Wu (The Guangxi Zhuang Autonomous Region People's Hospital, Nanning); Guangyi Wang (PLA General Hospital, Beijing); Guangyuan Song (Fuwai Hospital, Beijing); Jianan Wang (The Second Affiliated Hospital of Medical College of Zhejiang University, Hangzhou); Jianfang Luo (Guangdong Provincial People's Hospital, Guangzhou); Junbo Ge (Zhongshan Hospital Affiliated to Fudan University, Shanghai); Kefang Guo (Zhongshan Hospital Affiliated to Fudan University, Shanghai); Lihua Guan (Zhongshan Hospital Affiliated to Fudan University, Shanghai); Mao Chen (West China Hospital of Sichuan University, Chengdu); Rong Yang (The First Affiliated Hospital of Nanjing Medical University, Nanjing); Shiliang Jiang (Fuwai Hospital, Beijing); Weifeng Wu (The First Affiliated Hospital of Guangxi Medical University, Nanning); Weihua Zhang (Yan'an Hospital, Kunming); Wei Ma (Peking University First Hospital, Beijing); Wenzhi Pan (Zhongshan Hospital Affiliated to Fudan University, Shanghai); Xiangqing Kong (The First Affiliated Hospital of Nanjing Medical University, Nanjing); Xianxian Zhao (Changhai Hospital of Second Military Medical University of Chinese PLA, Shanghai); Xianyang Zhu (General Hospital of Shenyang Military Region, Shenyang); Xianying Liu (The Second Affiliated Hospital of Medical College of Zhejiang University, Hangzhou); Xue Yang (Zhongshan Hospital Affiliated to Fudan University, Shanghai); Yong Huo (Peking University First Hospital, Beijing); Yongjian Wu (Fuwai Hospital, Beijing); Yong Sun (The Second Affiliated Hospital of Harbin Medical University, Harbin); Yongwen Qin (Changhai Hospital of Second Military Medical University of Chinese PLA, Shanghai); Yuan Feng (West China Hospital of Sichuan University, Chengdu); Yushun Zhang (The First Affiliated Hospital of Xi'an Jiao Tong University, Xi'an); Zhiyuan Song (Southwest Hospital of Third Military Medical University, Chongqing); Zhi Zeng (West China Hospital of Sichuan University, Chengdu); Zhiwei Zhang (Guangdong Provincial People's Hospital, Guangzhou); Zhongying Xu (Fuwai Hospital, Beijing)

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
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