A risk- scoring system using the STS database has been developed to predict surgical risk in patients with IE to help better counsel patients and more objec- tively define the risks associated with surgery. One trial noted that even when surgery is indicated, women were less likely to undergo a surgical procedure than men (26% versus 47%) and that women had higher in-hospital and 1-year mortality rates than men despite similar comorbidities.1,2,4 6 CLINICAL STATEMENTS AND GUIDELINES 2. Studies have reported a 21% in-hospital mor- tality rate in patients with IE and HF who were treated with surgery versus a 45% mortality rate in those who were treated medically. In left- heart native valve endocarditis, 4 baseline fea- tures have been independently associated with 6-month mortality: 1) abnormal mental status, 2) moderate to severe HF, 3) bacterial etiology other than Viridans streptococci, and 4) medical therapy without valve surgery. Except in inject- able drug users, the risk of reinfection after prosthetic valve surgery is low relative to the risk associated with not having surgery in patients with hemodynamic and microbial indications for surgery. Prosthetic valve endocarditis is clearly associated with both higher mortality rates (especially with HF, severe valvular dysfunction, or a staphylococcal or fungal infectious microbe) and higher post-treatment HF-related disability. Surgical series report surgical rates of 50% in patients with prosthetic valve endocarditis, and these patients show improved outcomes over medical therapy, even with controlling for sever- ity of illness at time of diagnosis.8,9,15 19 3. Compared with patients with IE attributable to other organisms, patients with left-sided S. aureus IE were significantly more likely to die (20% versus 12%), experience an embolic event (60% versus 31%), have a central nervous sys- tem event (20% versus 13%), and not undergo surgery (26% versus 39%). Staphylococcal pros- thetic valve endocarditis has been associated with a mortality rate as high as 70%, which is driven by resistant staphylococcal species. When Staphylococcus is the bacteria, death occurs in <5% of patients with right-sided native valve Figure 16. Endocarditis treatment. Colors correspond to Table 2. *IE caused by streptococcus, E. faecalis, S. aureus, or coagulase-negative staphylococci deemed stable by the Heart Valve Team. Early surgery defined as during initial hospital course and before completion of a full course of appropriate antibiotics. In patients with an indication for surgery and a stroke but no evidence of intracranial hemorrhage or extensive neurological damage, surgery without delay may be considered. DUA indicates drug use as- sociated endocarditis; HF, heart failure; ICD, implantable cardioverter-defibrillator; ID, infectious disease; IE, infective endocarditis; IV, intravenous; NVE, native valve endocarditis; OST, opioid substitution treatment; pt, patient; PVE, prosthetic valve endocarditis; Rx, therapy; S. aureus, Staphylococcus aureus; TEE, transesopha- geal echocardiography; TTE, transthoracic echocardiography; VHD, valvular heart disease; and VKA, vitamin K antagonist. CLINICAL STATEMENTS AND GUIDELINES endocarditis, which is an important distinction in injectable drug users. Certain pathogens, such as Pseudomonas aeruginosa, Brucella, fungi, enterococci, and gram-positive cocci are extremely difficult to cure with medical therapy alone and are also prone to abscess or fistula for- mation and other cardiac tissue destruction. The mortality rate is also significantly lower in patients treated with antifungal agents combined with surgery than in those treated with antifungal agents alone (42% versus 59%).9,15,20,22,28 35 4. Abscess in native valve endocarditis is a life- threatening complication that cannot be cured with antibiotic therapy alone. Extensive para- valvular infections (including annular or aortic abscesses and destructive penetrating lesions or fistulae) are associated with a mortality rate of 40% and heart block. The long-term results of surgery are very satisfactory, with an actuarial survival rate of 75% 6% at 5 years. Freedom from recurrent IE has been reported to be 76% at 8 years. Surgical series have shown that the surgical results are related more to a surgeon s ability to remove all infected tissues and recon- struct functional anatomy than to the type of valve used for a replacement. Patients with prosthetic valve endocarditis complicated by paravalvular invasion, as manifested by intracar- diac abscesses, fistulae, or heart block, experi- ence high mortality rates and are rarely cured by medical treatment alone. By contrast, surgi- cal series have reported surgical survival rates of 71% in this high-risk group.9,41 44 5. Blood culture samples will typically become nega- tive after 48 hours of appropriate antimicrobial therapy, except for with methicillin-resistant S. aureus and other resistant organisms, for which it may take up to a week for cultures to become negative. Some caution is advised in patients who develop recurrent fever after an initially successful response to antibiotics because the fever could be explained by reasons other than the endocarditic valve. Ongoing infection despite antibiotic ther- apy is common with aggressive microorganisms, resulting in abscess formation, valve destruction, fistulas, or large vegetations.7,9,15,46,48 6. Optimal therapy for cardiac device IE combines complete device extraction and a prolonged course of parenteral antibiotics with complete device and lead removal, even if evidence for infection appears to be limited to the generator pocket site. A prospective cohort study using data from the ICE-PCS (International Collaboration on Endocarditis Prospective Cohort Study) showed that among patients with cardiac device IE, the rates of both concomitant valve infection and mortality are high, particularly if there is valve dysfunction. A proportional hazards regression analysis showed a survival benefit at 1 year for device removal during the initial hospitalization; device removal during the index hospitalization had died at 1 year, versus 13 of 34 (38.2%) who did not undergo device removal (HR: 0.42; 95% 7. Relapsing infections may be caused by incom- plete sterilization of valvular or paravalvular tis- sue secondary to a deep tissue infection. Even in the absence of other indications for intervention, such as severe valve dysfunction or a resistant organism, if there is no other source for persis- tent bacteremia, heart valve infection must be presumed to be the source. If the source of infec- tion is uncertain, additional imaging with PET/CT may be helpful in decision-making.7 8. The incidence of drug use associated IE continues to rise, with a known risk of IE that is 100-fold higher than that of the general population. In a National Institutes of Health sponsored state- wide health survey in the state of North Carolina, 42% of all IE valve surgeries performed between 2007 and 2017 were undertaken in patients with injection drug use related IE. The care of these patients is associated with longer hospital stays, higher readmission rates, higher rates of recurrent IE, and higher costs of care. With evolving sci- ence in addiction medicine, there is evidence that referral to addiction therapy can reduce mortality and morbidity rates in these patients. In patients admitted with drug use associated endocarditis, addiction specialists are an integral part of the 9. Embolic events are associated with increased morbidity and mortality in IE and occur in 20% to 40% of patients with IE. The risk of embo- lism is highest during the first days after initia- tion of antibiotic treatment and decreases after 2 weeks. Embolic incidence decreases to 9% to 21% after initiation of antibiotic treatment. Factors associated with a new embolic event are vegetation size >10 mm and marked vegetation mobility (especially when associated with the anterior leaflet of the mitral valve). Early sur- gery is associated with a reduction in the rate of embolic complications in patients who present with left-sided IE, severe VHD, and large vegeta- With native valve endocarditis, large vegetation size is associated with a markedly higher rate of embolic phenomena. In an RCT of surgical intervention in patients with severe left-sided valve dysfunction and vegetations >10 mm in CLINICAL STATEMENTS AND GUIDELINES length (even in the absence of clinically appar- ent embolic events or HF), there was no signifi- cant difference in all-cause mortality rate at 6 months in the early surgery versus the conven- tional treatment groups (3% and 5%, respec- tively; P=0.59); however, there was a marked reduction in the number of embolic events: 0% in the early surgery group compared with 21% in the conventional treatment group (P=0.005). Additionally, 77% of the conventional treat- ment group required surgery during the initial hospitalization or during the follow-up phase secondary to HF, paravalvular extension, and Stroke is an independent risk factor for postoperative death in patients with IE. Recommendations about the timing of opera- tive intervention after a stroke in the setting of IE are hindered by the lack of RCTs and reliance on single-center experiences. In early observa- tional data, there was a significantly decreased risk of in-hospital death when surgery was per- formed >4 weeks after the stroke.73 These data were not risk adjusted. In an observational study that did adjust for factors such as age, para- valvular abscess, and HF, the risk of in-hospital death was not significantly higher in the group who underwent surgery within a median time from admission to operation of 5 days, with only a 1% risk of perioperative hemorrhagic Patients with hemorrhagic stroke and IE have a prohibitively high surgical risk for at least 4 weeks after the hemorrhagic event. One multicenter showed wide variation in patient deaths when those who underwent sur- gery within 4 weeks of a hemorrhagic stroke were compared with those whose surgery was delayed until after 4 weeks (75% versus 40%, respectively). The percentage of new postop- erative bleeds was 50% in patients whose sur- gery was performed in the first 2 weeks, 33% in patients whose surgery was performed in the third week, and 20% in patients whose surgery was performed at least 21 days after the neuro- 13. PREGNANCY AND VHD The physiological hemodynamic changes associated with pregnancy are usually well tolerated in women with structurally normal hearts. However, for women with VHD, the hemodynamic burden may pose signifi- cant challenges during pregnancy and delivery. 13.1. Initial Management of Women With VHD Before and During Pregnancy Recommendations for Initial Management of Women With VHD Before and During Pregnancy Referenced studies that support the recommendations are summarized in Online Data Supplement 43. COR LOE Recommendations Women with suspected valve disease who are considering pregnancy should undergo a clinical evaluation and TTE before pregnancy.1 5 Women with severe valve disease (Stages C and D) who are considering pregnancy should undergo pre-pregnancy counseling by a cardiologist with expertise in managing women with VHD during pregnancy.1 5 Pregnant women with severe valve disease (Stages C and D) should be monitored in a tertiary-care center with a dedicated Heart Valve Team of cardiologists, surgeons, anesthesiologists, and maternal-fetal medicine obstetricians with expertise in the management of high-risk cardiac conditions during pregnancy.1 12 In asymptomatic women with severe valve disease (Stage C1) who are considering pregnancy, exercise testing is reasonable before pregnancy for risk assessment.3 5,11,13 15 Synopsis To assure the best possible outcome for a woman with VHD and her baby, a comprehensive evaluation is best performed before the time of conception. During preg- nancy, the frequency and intensity of follow-up and treatment are heavily dependent on the type and sever- ity of valve lesion, as well as patient symptoms. Recommendation-Specific Supportive Text 1. The risks to the mother and fetus during preg- nancy are highly dependent on the type and sever- ity of valve disease. Clinical evaluation of women with VHD who are contemplating pregnancy includes a complete TTE with full anatomic and hemodynamic assessment of the valves.1 5 A con- genital bicuspid or unicuspid aortic valve is often associated with dilation of the aortic sinuses, the ascending aorta, or both. Evaluation of women with a congenitally abnormal aortic valve includes assessment of the aorta before pregnancy because of the risk of further aortic enlargement and aortic dissection during pregnancy.1 5 2. Pre-pregnancy counseling with a cardiologist expe- rienced with managing women with valve disease during pregnancy allows discussion of the risks of pregnancy for the mother and fetus. A complete assessment of functional capacity, severity of valve lesions, status of the LV and RV, and pulmonary CLINICAL STATEMENTS AND GUIDELINES pressures is necessary to determine the risk of pregnancy and delivery. Medications are reviewed to avoid agents that may have potential harmful effects on the fetus. Pre-pregnancy evaluation also allows discussion of options for interventions before pregnancy, such as valve replacement, valve repair, or percutaneous aortic or mitral balloon dilation, particularly in those patients with severe rheumatic MS or AS.1 5 3. Women with severe valve disease who become pregnant are at an elevated risk of cardiac morbid- ity and mortality. Babies born to such mothers are also at risk of serious complications. Identification and management of complications are improved by monitoring in a tertiary-care center with an experienced team of healthcare providers who have expertise in managing high-risk cardiac con- ditions during pregnancy.1 12 4. Patients with severe valve disease may be asymp- tomatic, which can pose a diagnostic and thera- peutic dilemma in women with these disorders who are considering pregnancy. Exercise testing is reasonable to assist with risk assessment in patients in whom it is unclear whether pregnancy can be tolerated without an intervention to repair or replace the valve before pregnancy.3 5,11,13 15 Symptoms provoked by exercise testing are syn- onymous with spontaneous symptoms. Patients who develop symptoms on exercise testing should be treated as having symptomatic valve disease (Stage D), and should undergo pre-preg- nancy counseling by a cardiologist with expertise in managing women with VHD during pregnancy 13.1.1. Medical Therapy for Women With VHD Before and During Pregnancy Recommendations for Medical Therapy of Pregnant Women With VHD Referenced studies that support the recommendations are summarized in Online Data Supplement 43. COR LOE Recommendations In pregnant women with VHD, beta-blocker medications are reasonable as required for heart rate control or treatment of In pregnant women with VHD and HF symptoms (Stage D), diuretic medications are reasonable if needed for volume overload.7,8 3: Harm B-NR In pregnant women with VHD, ACE inhibitors and ARBs should not be given because of fetal Synopsis Women with severe VHD are at risk of HF, arrhythmia, and other cardiac disorders during pregnancy. Although medical therapy may be necessary to preserve the moth- er s health, there may be negative consequences for the fetus. Therefore, the fetal effects of cardiac medications must be understood so that the appropriate risks and benefits can be weighed.1 6 Data from ROPAC (Registry On Pregnancy And Cardiac Disease), a large multicenter registry supported by the European Society of Cardiol- ogy, showed an association between the use of cardiac medications during pregnancy and adverse fetal out- come. This association was attributable, in part, to the associated maternal cardiac diseases that required the Anticoagulation for pregnant women with AF should conform to the guidelines in nonpregnant Recommendations for anticoagulation regi- mens during pregnancy are discussed in section 13.2.2. Recommendation-Specific Supportive Text 1. Beta-blocker medications are used to control heart rate or to treat arrhythmias. However, maternal use of beta blockers has been associated with a newborn birth weight approximately 100 g lower than that of newborns whose mothers did not take beta blockers.6 The use of beta blockers with beta-1 selectivity avoids the beta-2 effects on uterine relaxation. The incidence of fetal growth retardation is lower with metoprolol treatment than with atenolol treatment in pregnancy.1 6 2. Diuretic medications can alleviate the effects of vol- ume overload in pregnant women with VHD and HF symptoms (Stage D). However, reduction of volume overload must be balanced against the reduction in placental blood flow associated with diuretic medi- Additionally, data from ROPAC suggested that maternal diuretic use was associated with rates of low birth weight and fetal mortality that were higher than for women not taking any medications. In part, this association was attributable to the severity of the underlying HF requiring treatment.7,8 3. ACE inhibitors and ARBs are strongly associated with fetal malformations when used by women 13.1.2. Intervention for Women With Native VHD Before and During Pregnancy 13.1.2.1. Pre-Pregnancy Intervention Recommendations for Pre-Pregnancy Intervention in Women With VHD Referenced studies that support the recommendations are summarized in Online Data Supplement 43. COR LOE Recommendations In symptomatic women with severe VHD who are considering pregnancy, intervention before pregnancy is recommended on the basis of CLINICAL STATEMENTS AND GUIDELINES In women who require a valve intervention before pregnancy, the choice of prosthetic valve should be based on a shared decision- making process that accounts for the patient s values and preferences, including discussion of the risks of mechanical valves during pregnancy and the reduced durability of bioprosthetic valves in young women. In asymptomatic women with severe rheumatic MS (mitral valve area 1.5 cm2 , Stage C1) who are considering pregnancy, PMBC at a Comprehensive Valve Center is reasonable before pregnancy for those who have favorable valve morphology.1 5,12,13 In women of childbearing age who require valve replacement, bioprosthetic valves are preferred over mechanical valves because of the increased maternal and fetal risks of mechanical heart valves in pregnancy.14 In asymptomatic women with severe AS (aortic velocity 4.0 m/s or mean pressure gradient 40 mmHg, Stage C) who are considering pregnancy, valve intervention before pregnancy is reasonable. In asymptomatic women with severe AS (aortic velocity 4.0 m/s or mean pressure gradient 40 mmHg, Stage C1) who are considering pregnancy, do not meet COR 1 criteria for intervention, and have a preconception evaluation confirming the absence of symptoms (including normal exercise stress testing and serum BNP measurements), medical management during pregnancy may be considered to avoid prosthetic valve replacement. In asymptomatic women with severe MR (Stage C1) and a valve suitable for repair who are considering pregnancy, valve repair before pregnancy at a Comprehensive Valve Center may be considered but only after detailed discussion with the patient about the risks and benefits of the surgery and its effect on future pregnancies. Synopsis In women with severe VHD who are considering preg- nancy, the indications for considering intervention in- clude the presence of symptoms, asymptomatic severe AS, asymptomatic severe MR with a repairable valve, and asymptomatic severe rheumatic MS with a valve morphol- ogy suitable for PMBC. If a prosthetic valve is needed, the shared decision-making process about the choice of type of prosthetic valve should include discussion of the risks of valve thrombosis and adverse effects from anticoagula- tion with mechanical valves versus the reduced durability of bioprosthetic valves in young women (Figure 17). Recommendation-Specific Supportive Text 1. Standard indications for intervention in symptom- atic patients with severe valve disease also apply to women who are considering pregnancy.1 11 2. Women of childbearing age who require valve intervention have important choices to make about the risks and benefits of the types of pros- thetic valves. The risks to the mother and fetus of valve thrombosis and anticoagulation dur- ing pregnancy with a mechanical valve must be weighed against the reduced durability of bio- prosthetic valves in young women. For women considering a mechanical prosthesis, it has been proposed that they undergo a preoperative trial of anticoagulation with warfarin to assess the dose needed to achieve a target INR. In 1 small study, women who required <5 mg daily of warfarin and then underwent subsequent mechanical AVR did not experience maternal or fetal complica- tions during pregnancy.15 Larger trials are needed, however, before this becomes standard practice. Shared decision-making with a cardiologist with expertise in the management of severe valve dis- ease during pregnancy allows discussion of these issues in women of childbearing age before valve surgery, even when pregnancy is not planned in the near future.1,14,16 3. Severe rheumatic MS presents a significant risk of maternal adverse outcome during pregnancy. In asymptomatic women with severe rheumatic MS (mitral valve area 1.5 cm2 , Stage C) and favor- able valve morphology who are considering preg- nancy, PMBC results in an increase in mitral valve area and reduction in transmitral gradient, which makes the patient more resilient to the hemody- namic load of pregnancy.1 5,12,13 4. Pregnant women with a bioprosthetic valve, compared with women with a mechanical valve who are on anticoagulation, have a lower risk of valve thrombosis, excessive bleeding, and fetal and maternal death.14 The Ross procedure is an alternative if performed in women with favor- able anatomy and at centers with expertise in the procedure. 5. Most patients with mild to moderate AS can tol- erate the hemodynamic changes of pregnancy without cardiovascular events. Patients with severe AS are at an increased risk of complica- tions, with HF developing in 10% to 44% of patients and arrhythmias in up to 25%, even if they were asymptomatic before pregnancy. Progressive as well as sudden deterioration may occur during pregnancy and delivery in patients with severe AS. Fetal complications are frequent also. Options for relief of valvular AS in young women include percutaneous aortic balloon dilation in patients with noncalcified congeni- tal AS, the Ross procedure, or a surgical bio- prosthetic or mechanical valve. TAVI has not been studied in young women, and few data Recommendations for Pre-Pregnancy Intervention in Women With VHD (Continued) COR LOE Recommendations CLINICAL STATEMENTS AND GUIDELINES exist on outcomes with this valve type during 6. Some women with severe asymptomatic AS, normal LV systolic function, and normal bio- markers may choose to undergo pregnancy without valve intervention. The risks of dete- rioration during pregnancy must be balanced against the risk of mechanical valve complica- tions during pregnancy or the long-term risks of a bioprosthetic valve in a young patient. In experienced centers, these women can often be treated with activity restriction, volume management, and optimization of loading 7. The threshold for valve operation for valve regurgitation is higher in the asymptomatic patient who might ever become pregnant than in patients who will not become pregnant because there always is the possibility that valve repair will not be successful and a prosthetic valve will be needed. Most patients with asymp- tomatic severe MR tolerate the hemodynamic changes of pregnancy, and there is no evidence for acceleration of LV dysfunction during preg- nancy. High-risk features for development of HF during pregnancy in women with MR include depressed LV systolic function and pulmonary hypertension (pulmonary artery systolic pressure >50 mm Hg). In high-risk asymptomatic women with severe MR, referral to a Comprehensive Valve Center allows consideration of mitral valve morphology, the likelihood of a successful valve repair, and estimated surgical risk in the Figure 17. Preconception management of women with native valve disease. Colors correspond to Table 2. TTE indicates transthoracic echocardiography; and VHD, valvular heart disease. CLINICAL STATEMENTS AND GUIDELINES 13.1.2.2. During-Pregnancy Intervention Recommendations for Intervention During Pregnancy in Women With VHD Referenced studies that support the recommendations are summarized in Online Data Supplement 43. COR LOE Recommendations In pregnant women with severe AS (mean pressure gradient 40 mmHg, Stage D), valve intervention during pregnancy is reasonable if there is hemodynamic deterioration or if there are NYHA class III or IV HF symptoms.1 7 In pregnant women with severe rheumatic MS (mitral valve area 1.5 cm2 , Stage D) and with valve morphology favorable for PMBC who remain symptomatic with NYHA class III or IV HF symptoms despite medical therapy, PMBC is reasonable during pregnancy if it is performed at a Comprehensive Valve Center.8 12 In pregnant women with severe valve regurgitation and with NYHA class IV HF symptoms (Stage D) refractory to medical therapy, valve surgery is reasonable during pregnancy.13 16 3: Harm C-LD In pregnant women with VHD, valve surgeries should not be performed in the absence of severe HF symptoms refractory to medical Synopsis In pregnant women with severe VHD who develop se- vere, intractable symptoms despite maximal medical therapy, surgical or percutaneous intervention may be- come necessary. Recommendation-Specific Supportive Text 1. Patients with severe AS may develop progressive HF or sudden hemodynamic deterioration during the stress of pregnancy. Both open heart surgery and percutaneous balloon dilation of the aortic valve are high-risk procedures during pregnancy for both the mother and the fetus and should be performed only if there is hemodynamic deterio- ration or if there are severe NYHA class III or IV HF symptoms. The type of intervention will be dependent on the valve morphology and on the expertise of the center. The intervention should always be performed in a center with a multidis- ciplinary group of cardiologists, interventionalists, cardiac anesthesiologists, and obstetricians spe- cializing in high-risk obstetrics.1 7,9 12 2. Patients with severe rheumatic MS may develop progressive HF or sudden hemodynamic deteriora- tion during the hemodynamic stress of pregnancy. Percutaneous balloon dilation of the mitral valve is a high-risk procedure during pregnancy for both the mother and the fetus and should be performed only if there is hemodynamic deterioration or if there are severe NYHA class III or IV HF symptoms.17 19 The intervention will also be dependent on an accept- able valve morphology. The intervention should always be performed in a center with a multidisci- plinary group of cardiologists, interventionalists, car- diac anesthesiologists, and obstetricians specializing in high-risk obstetrics.1 7,9 12,20 3. Regurgitant valve lesions are generally better toler- ated during pregnancy than are stenotic ones. Valve surgeryisreasonableonlyintherarepregnantwoman with severe valve regurgitation with NYHA class IV HF symptoms refractory to medical therapy.13 16 4. Valve surgery during pregnancy is high risk, with a 30% to 40% fetal mortality rate and up to 9% maternal mortality rate reported. It should be reserved only for patients with severe, intractable symptoms unresponsive to bed rest and maxi- mally tolerated medical therapy.13 16 13.2. Prosthetic Valves in Pregnant Women 13.2.1. Initial Management Recommendations for Initial Management of Prosthetic Heart Valves in Pregnant Women Referenced studies that support the recommendations are summarized in Online Data Supplement 44. COR LOE Recommendations Women with a prosthetic valve should undergo pre-pregnancy assessment, including echocardiography, by a cardiologist with expertise in managing women with VHD during pregnancy. Pregnant women with a mechanical prosthesis should be monitored in a tertiary-care center with a dedicated MDT of cardiologists, surgeons, anesthesiologists, and maternal-fetal medicine obstetricians with expertise in the management of high-risk cardiac conditions Women with mechanical heart valves considering pregnancy should be counselled that pregnancy is high risk and that there is no anticoagulation strategy that is consistently safe for the mother and baby.3 6 Pregnant women with a mechanical prosthetic valve who have prosthetic valve obstruction or experience an embolic event should undergo Synopsis Pregnancy in women with mechanical heart valves is very high risk and has been classified by the World Health Or- ganization as Risk Category III (significantly increased risk of maternal mortality or severe morbidity). Contemporary studies and prospective registries of pregnancy in women with mechanical heart valves confirm that maternal risk re- mains high: Maternal mortality rate is approximately 1%, and the risk of valve thrombosis is approximately 5%.2,5,9 Given the substantial risk of adverse maternal and fetal CLINICAL STATEMENTS AND GUIDELINES events, there is a need for specialized expertise in the coun- seling and care of women with prosthetic heart valves who are considering pregnancy or who are pregnant. Recommendation-Specific Supportive Text 1. A preconception TTE is used to assess valve func- tion, ventricular function, and pulmonary artery systolic pressure. Preconception TTE can help identify women with valve dysfunction who may benefit from valve intervention before concep- tion. Results can facilitate patient counseling about specific risks of pregnancy. 2. The management of prosthetic heart valves during pregnancy is substantially different from the man- agement of prosthetic heart valves in a nonpregnant patient. There is a much higher risk of mechanical valve thrombosis during pregnancy because of the hypercoagulable state. Choosing the appro- priate anticoagulation strategy to balance risks to the mother and fetus requires a team familiar with management of prosthetic heart valves in preg- nancy to provide comprehensive counseling. The management of anticoagulation also requires spe- cialized expertise, and frequent titration of VKA or heparin doses is needed.2,10 Transvalvular gradients increase during pregnancy because of increased heart rate, plasma volume, and stroke volume.1 In the event that valve intervention is required during pregnancy, the comprehensive Heart Valve Team and maternal-fetal medicine team is required to optimize maternal and fetal outcomes. 3. Each anticoagulation strategy has relative advan- tages and disadvantages in terms of maternal and fetal safety, but there is no anticoagulation strat- egy that is consistently safe for the mother and fetus. The maternal mortality rate is >1%, and seri- ous maternal and fetal complications are common, even with modern mechanical heart valves and After counseling, some women with mechanical heart valves may choose not to become pregnant, whereas others may wish to proceed with pregnancy, so comprehensive and candid counseling about the risks of pregnancy with a mechanical heart valve is important. 4. Pregnancy is a time of increased risk of mechani- cal valve thrombosis, so there should be high suspicion of valve thrombosis in women with an embolic event, clinical deterioration, symptoms of HF, or a pronounced increase in valve gradients or valve regurgitation during pregnancy. TEE is use- ful to visualize leaflet motion and thrombus bur- den. Fluoroscopy and gated cardiac CT are also useful in evaluating patients with suspected valve 13.2.2. Anticoagulation for Pregnant Women With Mechanical Prosthetic Heart Valves Recommendations for Anticoagulation for Pregnant Women With Mechanical Prosthetic Heart Valves Referenced studies that support the recommendations are summarized in Online Data Supplement 44. COR LOE Recommendations Pregnant women with mechanical prostheses should receive therapeutic anticoagulation with frequent monitoring during pregnancy.1 10 Women with mechanical heart valves who cannot maintain therapeutic anticoagulation with frequent monitoring should be counseled against pregnancy.7,8,10 15 Women with mechanical heart valves and their providers should use shared decision- making to choose an anticoagulation strategy for pregnancy. Women should be informed that VKA during pregnancy is associated with the lowest likelihood of maternal complications but the highest likelihood of miscarriage, fetal death, and congenital abnormalities, particularly if taken during the first trimester and if the warfarin dose Pregnant women with mechanical valve prostheses who are on warfarin should switch to twice-daily LMWH (with a target anti-Xa level of 0.8 U/mL to 1.2 U/mL at 4 to 6 hours after dose) or intravenous UFH (with an activated partial thromboplastin time [aPTT] 2 times control) at least 1 week before Pregnant women with mechanical valve prostheses who are on LMWH should switch to UFH (with an aPTT 2 times control) at least 36 hours before planned delivery.19 21 Pregnant women with valve prostheses should stop UFH at least 6 hours before planned vaginal delivery.19 21 If labor begins or urgent delivery is required in a woman therapeutically anticoagulated with a VKA, cesarean section should be performed after reversal of anticoagulation.3,22,23 For pregnant women with mechanical prostheses who require a dose of warfarin 5 mg/d to maintain a therapeutic INR, continuation of warfarin for all 3 trimesters is reasonable after full discussion with the patient about risks and benefits.3,6,16,18,22,24,25 For pregnant women with mechanical prostheses who require >5 mg/d of warfarin to achieve a therapeutic INR, dose-adjusted LMWH (with a target anti-Xa level of 0.8 to 1.2 U/mL at 4 to 6 hours after dose) at least 2 times per day during the first trimester, followed by warfarin during the second and third trimesters, is reasonable.3,6,15,16,25 For pregnant women with mechanical prostheses who require a dose of warfarin >5 mg/d to achieve a therapeutic INR, and for whom dose-adjusted LMWH is unavailable, dose-adjusted continuous intravenous UFH during the first trimester (with aPTT 2 times control), followed by warfarin for the second and third trimesters, is reasonable.3,6,11,16 CLINICAL STATEMENTS AND GUIDELINES For hemodynamically stable pregnant women with obstructive left-sided mechanical valve thrombosis, it is reasonable to manage with slow-infusion, low-dose fibrinolytic therapy.26 For pregnant women with mechanical prostheses who require a warfarin dose >5 mg/d to achieve a therapeutic INR, dose- adjusted LMWH (with a target anti-Xa level of 0.8 to 1.2 U/mL at 4 to 6 hours after dose) at least 2 times per day for all 3 trimesters may For pregnant women with mechanical prostheses who require a dose of warfarin 5 mg/d to maintain a therapeutic INR, dose-adjusted LMWH at least 2 times per day during the first trimester, followed by warfarin for the second and third trimesters, may be considered.1 3,6,12,16,22 For pregnant women with mechanical prostheses, aspirin 75 to 100 mg daily may be considered, in addition to anticoagulation, if needed for other indications.28 3: Harm B-NR For pregnant women with mechanical prostheses, LMWH should not be administered unless anti-Xa levels are monitored 4 to 6 hours after administration and dose is adjusted according to 3: Harm B-R For patients with mechanical valve prostheses, anticoagulation with the direct thrombin inhibitor, dabigatran, should not be 3: Harm C-EO The use of anti-Xa direct oral anticoagulants with mechanical heart valves in pregnancy has not been assessed and is not Synopsis Pregnant women with mechanical heart valves are at increased risk of serious maternal complications, in- cluding valve thrombosis, thromboembolism, hemor- rhage, and death. The risk of poor fetal outcomes is also high, with increased rates of spontaneous abor- tion, fetal death, fetal hemorrhage, and teratogenic- ity related to VKAs. For women with mechanical heart valves, the maternal mortality rate remains >1%. More than one-third of women with mechanical heart valves have a serious maternal or fetal complication during All women with mechanical heart valves require uninterrupted therapeutic anticoagulation throughout pregnancy. The choice of anticoagulation strategy is challenging because there are inherent trade-offs be- tween maternal safety and fetal safety. Warfarin is the most effective anticoagulant at preventing thrombotic complications, but warfarin crosses the placenta and can cause miscarriage, spontaneous abortion, war- farin embryopathy, or fetal intracranial hemorrhage. Although LMWH is not teratogenic, women with me- chanical heart valves on LMWH are at increased risk of thrombotic events, particularly when LMWH is im- properly dosed, monitored, or administered. There is no single optimal anticoagulation strategy that suits all women. There are 3 potential strategies: 1) Continue warfa- rin throughout pregnancy; 2) use heparin throughout pregnancy; and 3) use sequential therapy, with heparin during the first trimester and warfarin during the sec- ond and third trimesters (Figure 18). Recommendation-Specific Supportive Text 1. The risk of catastrophic valve failure or stroke is prohibitively high for women with mechanical heart valves who cannot take dose-adjusted and frequently monitored anticoagulation throughout 2. Much of the maternal morbidity and mortality during pregnancy occurs in women who are not receiving appropriate doses of anticoagulation because of improper administration, improper monitoring, or medication nonadherence. Women who are not able to receive therapeutic anticoagulation or do not have access to frequent monitoring and dose adjustment are at prohibi- tive risk for pregnancy.13 15 3. No anticoagulation strategy is optimally safe for both the mother and the fetus. Warfarin is saf- est for the mother but crosses the placenta and can cause fetal intracranial hemorrhage; fetal loss; and teratogenicity, particularly at doses >5 mg/d and when given during the first trimester, keeping in mind that the warfarin dose needed to maintain a therapeutic INR may change during pregnancy. Neither UFH nor LMWH crosses the placenta, but each is associated with higher rates of maternal complications than are seen with war- Depending on a woman s values and priorities, she may choose an antico- agulation strategy that minimizes maternal risk, minimizes fetal risk, or attempts to achieve a bal- ance between maternal and fetal risk. Physicians should not assume a woman s values or prefer- ences, nor should physicians supplant their own preferences for those of the patient. Counseling and shared decision-making allows for a woman and her physician to choose the best anticoagula- tion to achieve the woman s goals. 4. Warfarin crosses the placental barrier and results in anticoagulation of the fetus, as well as the mother. There is a higher risk of fetal intracra- nial hemorrhage if the mother is fully antico- agulated with warfarin during vaginal delivery. Women taking warfarin can minimize the risk Recommendations for Anticoagulation for Pregnant Women With Mechanical Prosthetic Heart Valves (Continued) COR LOE Recommendations CLINICAL STATEMENTS AND GUIDELINES Figure 18. Anticoagulation for prosthetic mechanical heart valves in women during pregnancy. Colors correspond to Table 2.*Dose-adjusted LMWH should be given at least 2 times per day, with close monitoring of anti-Xa levels. Target to Xa level of 0.8 to 1.2 U/mL, 4 to 6 hours after dose. Trough levels may aid in maintaining patient in therapeutic range. Continuous UFH should be adjusted to aPTT 2 times control. aPTT indicates activated partial thromboplastin time; IV, intravenous; LMWH, low-molecular-weight heparin; UFH, unfractionated heparin; and VKA, vitamin K antagonist. CLINICAL STATEMENTS AND GUIDELINES by switching to a heparin preparation before 5. Although LMWH does not result in an antico- agulated fetus, the risk of maternal hemorrhage is high if delivery occurs while the mother is on LMWH. Therefore, it is recommended that the mother be hospitalized before planned delivery, with discontinuation of long-acting anticoagu- lation and initiation of intravenous continuous infusion of UFH to keep aPTT >2 times control 6. Intravenous heparin should be stopped long enough before delivery to reduce risk of mater- nal bleeding and allow safe placement of epidural anesthesia (typically at least 6 hours). Exact tim- ing should be coordinated with the obstetrics and 7. Because warfarin results in an anticoagulated fetus, there is a high risk of fetal intracranial hemorrhage if vaginal delivery is attempted in a woman who is anticoagulated with warfarin. If a woman goes into labor while on warfarin, appropriate reversal of anticoagulation followed by cesarean section reduces the risk of fetal intra- 8. The teratogenic effects of warfarin are dose dependent. The rate of warfarin embryopathy is reduced (<3%) but not eliminated if the daily dose of warfarin is 5 mg/d.3,6.16,18,23,25,36,37 In most women, the effective dose of warfarin typically does not vary significantly during pregnancy.38 For women who require a dose 5 mg/d, continua- tion of low-dose warfarin throughout pregnancy poses the lowest combined risk to mother and The number of reported pregnancies on low-dose warfarin is relatively small, and not all publications have found improved fetal out- comes on low-dose warfarin,11 so caution should be exercised until more data are available. 9. If warfarin is taken in doses >5 mg/d during the first trimester of pregnancy, there is a >30% risk of fetal loss or embryopathy. For women who require >5 mg/d to maintain a therapeutic INR, replac- ing warfarin with dose-adjusted LWMH during the first trimester reduces fetal loss.3,6,10,15,16,23,39,40 While the patient is taking LMWH, anti-Xa levels should be monitored at least weekly and the dose adjusted accordingly. Fixed dosing is never appro- priate, because it is associated with high maternal morbidity and mortality.41 After the first trimester, the fetal toxicity of warfarin is substantially lower, so switching back to warfarin for the second and third trimesters results in a reasonable balance between maternal safety and fetal safety. 10. In regions where LMWH is unavailable or cost-pro- hibitive, or if anti-Xa levels cannot be monitored, continuous infusion of UFH can be used as an alternative to LMWH during the first trimester for women who require a warfarin dose of >5 mg/d.37 If UFH is used during the first trimester, the dose should be adjusted to maintain an aPTT 2 times control. There are several disadvantages to UFH compared with LMWH: Women are at greater risk for line infections, osteoporosis, and hepa- rin-induced thrombocytopenia, so UFH should be reserved for situations where dose-adjusted LMWH is not feasible.10 Intermittent subcutane- ous injection of UFH is not an acceptable alterna- tive because it is associated with prohibitive rates of valve thrombosis.42 UFH is associated with very high rates of valve thrombosis, stroke, and death in pregnant women with mechanical heart valves during the second and third trimesters.3,4,43 11. In carefully selected women with thrombosis of a mechanical heart valve during pregnancy, low- dose, slow-infusion, tissue-type plasminogen acti- vator (tPA) can be an alternative to surgical valve replacement. Women who are optimal candidates are hemodynamically stable and have obstructive prosthetic valve thrombosis, valve thrombosis with embolic complications, or nonobstructive valve thrombosis with a thrombus >10 mm.44 Given the high rates of fetal loss with cardiac surgery during pregnancy, thrombolysis is an attractive alterna- tive for appropriately selected, hemodynamically stable women with mechanical valve thrombosis. 12. Although the teratogenicity of warfarin is high- est during the first trimester, there is still a risk of pregnancy loss or fetal hemorrhage when warfarin is taken during the second and third trimesters. Therefore, after appropriate counsel- ing, some women may choose to avoid warfarin entirely throughout pregnancy. For these women, dose-adjusted LMWH throughout pregnancy is the safest alterative. LMWH throughout preg- nancy is associated with a higher rate of throm- botic complications than warfarin. However, many of the thrombotic events occur when LMWH is administered improperly or monitored erratically or if patients are nonadherent.8,14,15,39 When administered and monitored meticulously, LMWH can be safe.12 Effective dose monitoring includes weekly measurements of anti factor Xa levels, with additional monitoring after dose Measurement of trough levels to maintain a trough Xa level >0.6 IU/mL may help women maintain therapeutic anticoagulation while on LMWH.12,13 13. When warfarin is taken at a dose 5 mg/d, the risk of warfarin embryopathy is reduced but not entirely eliminated. Some women, after discussion with their physicians, may choose to substitute CLINICAL STATEMENTS AND GUIDELINES LMWH for low-dose warfarin during the first tri- mester to eliminate the risk of warfarin embry- opathy. This choice improves fetal outcomes but at the cost of increased maternal thrombotic 14. Low-dose aspirin is regarded as safe during preg- nancy and can be continued in women with mechanical heart valves if needed for other indi- cations. There may be noncardiac indications for aspirin in pregnant women, such as prevention of 15. Studies using subcutaneous LMWH at a fixed dose without monitoring of anti-Xa levels in preg- nant patients with mechanical prostheses found a high risk of valve thrombosis and maternal death. In pregnant women treated with dose-adjusted LMWH, the dose of LMWH required to maintain an adequate anti-Xa level 4 to 6 hours after admin- istration increases throughout pregnancy.9,15,39,41 16. A randomized clinical trial of dabigatran in non- pregnant patients with mechanical heart valves showed an increased rate of thromboembolic and bleeding complications with dabigatran com- pared with warfarin.45 The safety and effective- ness of anti-Xa direct oral anticoagulants has not been established in patients with mechanical heart valves. Additionally, the safety of anti-Xa direct oral anticoagulants in pregnancy is unknown.30 32 17. Anti-Xa direct oral anticoagulants have not been shown to be safe in patients with mechani- cal heart valves, so they should not be used in pregnancy. 14. SURGICAL CONSIDERATIONS Concomitant surgical procedures may be appropriate at the time of intervention for VHD in the interest of re- ducing periprocedural risk (eg, treatment of significant CAD) or for optimizing long-term outcomes (eg, adding a maze procedure for AF treatment). Consideration may also be given to treating moderate disease in the inter- est of obviating the need for subsequent reoperation for example, treating aortic dilation in the presence of a BAV. This is particularly true when one can anticipate particular difficulty in the conduct of a subsequent re- operation, as may be the case for mitral valve interven- tion after AVR or in a patient with prior mediastinal ir- radiation for whom postoperative adhesions are often severe. The benefits of such concomitant procedures must be balanced against the potential impact on peri- procedural risk due to added complexity. In particular, interventions that add significantly to aortic cross-clamp time may be discouraged in patients with poor LV func- tion or significant pulmonary hypertension. Prolonga- tion of cardiopulmonary bypass time may increase renal injury, particularly among those with preexisting renal dysfunction. More complex procedures may also pose a particular risk in patients with fragile tissue integrity or general frailty, and the additional dissection that may be required in a reoperative setting may tip the balance away from imposing additional risk by performing con- comitant procedures. 14.1. Evaluation and Management of CAD in Patients With VHD 14.1.1. Management of CAD in Patients Undergoing TAVI Recommendations for Management of CAD in Patients Undergoing TAVI Referenced studies that support the recommendations are summarized in Online Data Supplement 45. COR LOE Recommendations In patients undergoing TAVI, 1) contrast- enhanced coronary CT angiography (in patients with a low pretest probability for CAD) or 2) an invasive coronary angiogram is recommended to assess coronary anatomy and guide revascularization. In patients undergoing TAVI with significant left main or proximal CAD with or without angina, revascularization by PCI before TAVI is In patients with significant AS and significant CAD (luminal reduction >70% diameter, fractional flow reserve <0.8, instantaneous wave-free ratio <0.89) consisting of complex bifurcation left main and/or multivessel CAD with a SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) score >33, SAVR and CABG are reasonable and preferred over TAVI and PCI.3,4 Synopsis CAD is common among patients presenting with AS, particularly the elderly. In the surgical experience, con- comitant revascularization impacts long-term survival in a favorable way and is commonplace, as is preoperative coronary imaging. Similarly, there is an argument to be made for coronary revascularization among patients un- dergoing TAVI, although the effects on late outcomes are less well defined and may not be the same as for SAVR, given the different demographics and comorbid- ities of the TAVI versus SAVR populations. Nonetheless, at this point, diagnostic imaging and consideration of revascularization are appropriate (Figure 19). Recommendation-Specific Supportive Text 1. The prevalence of CAD in patients with severe AS ranges between 15% and 80%.5 and varies depending on the definition of CAD used and the The impact of CAD on outcomes is controversial,7,8 although one report CLINICAL STATEMENTS AND GUIDELINES singled out severe CAD (defined by a SYNTAX score >22) and incomplete revascularization as the only independent predictors of death after TAVI.9 Assessment of the coronary anatomy is important in patients with severe AS to rule out obstructive CAD. Invasive coronary angiography is commonly performed. In patients with a low pretest prob- ability of CAD, contrast-enhanced coronary CT has an excellent negative predictive In patients with normal renal function, an option is to combine contrast-enhanced coro- nary CT angiography with CT assessment of the peripheral circulation and heart structure as an ini- tial imaging test, reserving coronary angiography for the event that the contrast-enhanced coronary CT angiography is nondiagnostic or significant CAD is found. Invasive functional assessment of coronary lesions in TAVI candidates by using frac- tional flow reserve or instantaneous wave-free ratio is safe and feasible.13 15 Instantaneous wave- free ratio may be particularly attractive because it does not require the administration of a vaso- dilator and is less influenced by the effect of the stenotic aortic valve, although randomized clinical trials validating the utility of both are ongoing. 2. There are no RCTs to inform clinical practice on the benefits and timing of PCI in patients under- going TAVI. The decision to perform PCI is there- fore driven by myriad clinical factors (eg, presence of angina or ischemia, ability to take dual-anti- platelet therapy before TAVI) and anatomic fac- tors (eg, lesion location and complexity, technical feasibility) and should be individualized. Overall, nonrandomized studies suggest that PCI before TAVI is safe and feasible,1 even in patients with left main disease.2 Conceptually, pre-TAVI PCI also allows a safer procedure and circumvents future post-TAVI PCI, which can be occasionally challenging. Staged PCI before TAVI is a common strategy in clinical practice and is associated with lower contrast volume and renal failure than is the strategy of TAVI with concomitant PCI,1 although the timing of pre-TAVI PCI remains controversial. 3. Multiple RCTs have been conducted to define the optimal management of CAD in patients with- out VHD based on the SYNTAX score to define Figure 19. Management of CAD in patients undergoing valve interventions. Colors correspond to Table 2. *Including men age >40 years and postmenopausal women. AVR indicates aortic valve replacement; CAD, coronary artery disease; CABG, coronary artery bypass graft; CT, computed tomography; LV, left ventricular; MR, mitral regurgitation; PCI, percutaneous coronary intervention; SYNTAX, Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery; and TAVI, transcatheter aortic valve implantation. CLINICAL STATEMENTS AND GUIDELINES those least amenable to percutaneous treatment. Subsets of patients shown to have superior free- dom from major adverse cardiac events include those with complex left main disease and those with a SYNTAX score >33.3 Accordingly, a surgical approach is reasonable in this subset of patients. Among SAVR patients, revascularization for those with significant CAD (>50% stenosis) has been shown to impact late risk of mortality favorably.4 14.1.2. Management of CAD in Patients Undergoing Valve Surgery Recommendations for Management of CAD in Patients Undergoing Valve Surgery Referenced studies that support the recommendations are summarized in Online Data Supplement 45. COR LOE Recommendations In patients with symptoms of angina, objective evidence of ischemia, decreased LV systolic function, history of CAD, or coronary risk factors (including men >40 years of age and postmenopausal women), invasive coronary angiography is indicated before valve In patients with chronic severe secondary MR, invasive coronary angiography should be performed as part of the evaluation.9 11 In selected patients with a low to intermediate pretest probability of CAD, contrast-enhanced coronary CT angiography is reasonable to exclude the presence of significant obstructive In patients undergoing valve repair or replacement with significant proximal CAD ( 70% reduction in luminal diameter in major coronary arteries or 50% reduction in luminal diameter in the left main coronary artery and/or physiologically significance), CABG is reasonable for selective patients.19,20 Synopsis Coronary imaging in the setting of VHD defines anat- omy that may be at risk during surgery or interven- tion. Given their similar demographic profiles, CAD and VHD frequently coexist, and in the case of sec- ondary MR they have a pathophysiological link. Re- vascularization, in turn, can impact periprocedural risk or long-term outcome. In the case of secondary MR, revascularization may positively impact the valve dis- ease via reverse remodeling of the LV. In the surgical setting, where repeat intervention is at high cost to the patient, efforts are typically made to correct all surgically correctable disease present at the index op- eration. Accordingly, an aggressive approach to revas- cularization is appropriate. In the setting of percutane- ous interventions, however, the option of sequential interventions with interval tests of improvement may be appropriate. In either case, less invasive imaging via contrast-enhanced coronary CT angiography is in- creasingly adopted. Recommendation-Specific Supportive Text 1. CAD is frequently present among patients with and may contribute to angina pecto- ris among those with aortic valve disease.3,4 Knowledge of coronary anatomy contributes to risk stratification, in addition to directing concom- itant coronary revascularization. There is a very low prevalence of CAD among men <40 years of age and premenopausal women with no athero- sclerotic risk factors2,5 7 or history of mediastinal 2. Functional MR occurs in patients with structur- ally normal valve leaflets and chordae because of LV dysfunction, including regional wall motion abnormalities or global dilation with displace- ment of the papillary muscles, leaflet tethering, annular dilation, and decreased closing forces from reduced contractility.9 11 Because this LV dys- function may be attributable to CAD and accom- panying myocardial ischemia, the assessment of coronary anatomy status is necessary to complete the diagnosis and allow evaluation of revascular- ization options. 3. Contrast-enhanced coronary CT angiography is an alternative to coronary angiography among selected patients who are at low to intermediate pretest probability of CAD before valve surgery.12 This does not include patients who have active symptoms of angina, those with documented ischemia, or those with a prior history of CAD, all of whom should have selective coronary angi- ography. Recent studies, most often in the set- ting of a pre-TAVI evaluation, have demonstrated diagnostic sensitivity of >90%, specificity of 60% and accuracy of >90%.21 Contrast- enhanced coronary CT angiography may be safer than coronary angiography in selected patient populations, such as those with IE and vegeta- tions on the aortic valve. However, a positive con- trast-enhanced coronary CT angiogram, defined as the presence of epicardial CAD, requires con- firmation with invasive coronary angiography to establish the need for and extent of CABG. The risk of radiation exposure and renal failure because of the contrast injection should be taken into consideration. 4. The presence of uncorrected CAD has been shown to negatively impact both perioperative22,23 and late outcomes of surgery for VHD.19 . Accordingly, concomitant CABG has been favored. These stud- ies of concomitant CABG at the time of valve surgery have demonstrated little or no adverse impact on the acute perioperative mortality rate, despite increased cross-clamp and cardiopulmo- nary bypass times. Moreover, combined CABG CLINICAL STATEMENTS AND GUIDELINES and valve surgery reduces the rate of perioperative myocardial infarction, and incomplete revascular- ization is associated with greater postoperative LV systolic dysfunction and a reduced survival rate after surgery as compared with patients who receive complete revascularization. For more than a decade, improved myocardial preservation tech- niques have been associated with reduced overall operative mortality rates, and it has become stan- dard practice to bypass all significant coronary artery stenoses, when possible, in patients under- going valve surgery. In patients with a significant stenosis of the left anterior descending artery, a left internal thoracic artery graft should be used if possible. Hybrid PCI followed by surgical valve repair or replacement has been reported favor- ably but is restricted to patients at high risk with a combined surgical approach.20 14.2. Intervention for AF in Patients With VHD Recommendations for Intervention for AF in Patients With VHD Referenced studies that support the recommendations are summarized in Online Data Supplement 46. COR LOE Recommendations In patients with VHD and AF for whom surgical intervention is planned, the potential symptomatic benefits and additional procedural risks of adjunctive arrhythmia surgery at the time of cardiac valvular surgery should be discussed with the patient.1 11 For symptomatic patients with paroxysmal or persistent AF who are undergoing valvular surgery, surgical pulmonary vein isolation or a maze procedure can be beneficial to reduce symptoms and prevent recurrent For patients with AF or atrial flutter who are undergoing valve surgery, LA appendage ligation/excision is reasonable to reduce the risk of thromboembolic events.16 19 In patients undergoing LA surgical ablation of atrial arrhythmias and/or LA appendage ligation/excision, anticoagulation therapy is reasonable for at least 3 months after the 3: Harm B-NR For patients without atrial arrhythmias who are undergoing valvular surgery, LA appendage occlusion/exclusion/amputation is potentially Synopsis For patients undergoing valve surgery with symptom- atic AF or atrial flutter, concomitant maze procedure with or without atrial appendage occlusion/exclusion/ amputation is a proven treatment for the atrial arrhyth- mia but requires postoperative anticoagulation for at least 3 months after the procedure (Figure 20). Recommendation-Specific Supportive Text 1. Surgical ablations, including pulmonary vein isola- tion and atrial maze at the time of valvular surgery and other open cardiac operations, have been dem- onstrated in multiple studies to reduce the recur- rence of AF.5 11 Various approaches to pulmonary vein isolation and modified left atrial, right atrial, and bi-atrial maze procedures entail longer proce- dure times, with higher risks of operative complica- tions and permanent pacemaker implantation.1 4 These adverse outcomes, coupled with the lack of large randomized trial data confirming mortality and stroke benefit, should be examined with the patient. 2. The atrial maze procedure properly refers to a specific bi-atrial lesion set performed by a cut- and-sew technique or with tissue ablation tech- nologies, including cryoenergy or radiofrequency. Of note, the term maze is often loosely applied to many variations of the original lesion set that may be less effective. When performed with com- plete encirclement of the pulmonary veins, most commonly in combination with mitral valve repair or replacement but also with aortic or tricuspid valve procedures, the maze procedure affords freedom from AF with an efficacy similar to that of catheter-based approaches.1,2,12 15 Patients undergoing combined atrial maze procedure at the time of operation for MR have a greater free- dom from recurrent AF than those who did not have a maze procedure.11 In patients with recur- rent AF who are to undergo surgical correction of MR, catheter ablation is best deferred in favor of a concomitant surgical maze, thereby avoiding the potential complications of a catheter maze and a second procedure for the patient. 3. A reduction in thromboembolism has been demon- strated by LA ligation/excision, although the ben- efit is less evident in those patients who maintain Discontinuation of oral antico- agulation has also been associated with late stroke, highlighting that the LA appendage is not the exclusive source of all thrombi in patients with AF. Therefore, there are insufficient data to support rou- tine discontinuation of anticoagulation in patients with AF who are undergoing LA ligation/excision. 4. Ablation with radiofrequency/cryoenergy or atrial suture lines provides an endocardial thrombo- genic milieu, and in addition, surgical LA append- age occlusion can be incomplete.20 22 In the context of atrial arrhythmias, manipulation of the LA, and post-cardioversion/defibrillation stun- ning, atrial mechanical function can be slow to recover. The resultant stasis and thrombogenic endocardial lesions provide a nidus for thrombus development, placing this group of patients at CLINICAL STATEMENTS AND GUIDELINES risk of stroke. Nonrandomized registry data indi- cate that stroke in the first 3 months after cath- eter ablation is driven chiefly by discontinuation of oral anticoagulation.21 Both US and European guideline statements on catheter ablation rec- ommend (on the basis of expert opinion alone) anticoagulation during this periprocedural phase while the endocardium heals from the ablation. By analogy, patients who have had surgical abla- tion should be managed with at least 3 months of anticoagulation, regardless of their CHA2 - VASc risk score. Subsequent anticoagulation should be based on evaluation of arrhythmia recurrence in the context of their CHA2 -VASc score. Anticoagulation should also be given for at least 3 months after LA ligation/excision. For patients receiving bioprostheses, a VKA would be the preferred method of anticoagulation for the first 3 months (see Section 2.4.3). 5. A higher incidence of early AF in all patients after LA appendage occlusion/exclusion has been dem- Together with the recognition that most patients do not develop AF after surgery, pre- emptive LA appendage occlusion in patients with- out preexisting AF cannot be recommended. No stroke benefit has been observed in this group of patients with no preemptive history of AF. 15. NONCARDIAC SURGERY IN PATIENTS WITH VHD 15.1. Diagnosis of Patients With VHD Undergoing Noncardiac Surgery Recommendation for Diagnosis in Patients With VHD Undergoing Noncardiac Surgery COR LOE Recommendation In patients with clinically suspected moderate or greater degrees of valvular stenosis or regurgitation who are undergoing noncardiac surgery, preoperative echocardiography is recommended. Synopsis The evaluation of patients with VHD who are undergo- ing noncardiac surgery is dependent on the type and Figure 20. Intervention for AF in patients with VHD. Colors correspond to Table 2. AF indicates atrial fibrillation; LA, left atrial, and VHD, valvular heart disease. CLINICAL STATEMENTS AND GUIDELINES severity of VHD, including 1) the presence or absence of symptoms, 2) the severity of VHD, 3) the risk of noncar- diac intervention, 4) the response of the LV and/or RV to the overload caused by VHD, and 5) the pulmonary artery systolic pressure. If the patient meets standard criteria for a cardiac intervention, it is prudent to de- fer elective noncardiac procedures and proceed to valve However, in emergency situations, noncardiac surgery may be necessary in the presence of uncorrected severe valve disease. All patients with severe VHD who are undergoing noncardiac surgery benefit from an evaluation by a Heart Team consisting of a cardiologist, cardiac anesthesiologist, and cardiac surgeons, in conjunction with the surgeon performing the procedure. In patients with severe VHD who are un- dergoing low-risk surgical procedures or in patients with mild to moderate VHD, noninvasive monitoring in con- sultation with a cardiovascular anesthesiologist may be all that is needed. In patients with severe VHD who are undergoing elevated-risk noncardiac surgery, decisions should be made as to whether to proceed with the non- cardiac surgery and whether invasive hemodynamic or TEE imaging monitoring should be performed intraop- eratively and postoperatively in an intensive care setting. 