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2. Valvular Heart Disease

Question 2: In adult persons living with valvular heart disease, either untreated or surviving to discharge post invasive treatment with follow-up after invasive treatment of valvular heart disease that includes ascertainment of SCD, what is the risk of SCI (including SCD, heart block, and syncope) within 1 year? Where possible, stratify according to sex, age, and LVEF.

Fitness to drive with valvular heart disease is determined according to the nature of the valve disease, development of symptoms, and the risk of operating a motor vehicle (Table 2). In most cases, a patient’s functional status can guide driving recommendations because valvular heart disease might present with symptoms of HF and increase the risk of arrhythmias. SCI in this group of patients is largely related to the risk of ventricular arrythmias or SCD in patients with diminished EF or the risk of syncope due to advanced conduction system disease or heart block. For patients with left ventricular dysfunction, driving restrictions are analogous with those for patients with HF. After successful intervention, either transcatheter or surgical, driving may be resumed according to the type of intervention performed and recuperation required after the intervention. There is a lack of large scale, detailed driving-specific data in patients with either treated or untreated valvular heart disease. Because of the multiple nuances in patients with mixed valvular heart disease, concomitant CAD, or concomitant severe ventricular dysfunction, involvement of the expert multidisciplinary structural heart team will be required for some patient-specific driving recommendations.

Aortic stenosis

Aortic valve stenosis is the most common valvular heart disease in North America and Europe with the prevalence increasing as the population ages. Although up to one-half of patients with aortic stenosis are asymptomatic at the time of diagnosis, the incidence of sudden death is reported as approximately 1% per year. Mortality is strongly correlated with symptomatic status, including dyspnea, angina, and syncope, as well as arrhythmias. Furthermore, syncope is also a potential source of incapacitation in these patients. One single-centre study estimated the incidence of syncope in patients who were candidates for transcatheter aortic valve replacement (TAVR) was 7%.[33] Additionally, there has been a temporal increase in aortic stenosis as a cause of HF in men and women across the world.[34] Commercial driving is therefore recommended only in those who are in the lowest risk subgroup (ie, asymptomatic with no previous episodes of syncope or presyncope, no angina, and no left ventricular dysfunction). Only in this lowest-risk subgroup would the annual risk of sudden death be estimated to be < 1%.

TAVR has become the intervention of choice among older patients with severe calcific aortic stenosis across surgical risk groups. TAVR is now a class 1A recommendation in the American College of Cardiology/American Heart Association valvular heart disease guidelines in patients with severe symptomatic aortic stenosis aged 65 years and older.[35] The primary complications of concern post-TAVR that might limit fitness to drive include access-related complications and postoperative conduction system disease leading to bradyarrhythmias. The low-risk Placement of Aortic Transcatheter Valves 3 (PARTNER-3) trial showed low rates of transfemoral access-related complications, comparable with surgical aortic valve replacement.[36] There remains a paucity of data regarding the optimal management of postoperative conduction abnormalities. The Multidisciplinary, Multimodality, But Minimalist Approach to Transfemoral Transcatheter Aortic Valve Replacement (3MTAVR) study developed a clinical pathway to facilitate safe next-day discharge post-TAVR.[37] In this study, patients were discharged with a new intraventricular conduction delay in the absence of new high-grade atrioventricular (AV) block if the length of the QRS was stable or decreasing after 24 hours. There was a low rate of late heart block requiring permanent pacemaker (0.24%) and the rate of new permanent pacemaker implantation using these criteria for next-day discharge was 5.7%. This pathway is endorsed by the recent 2020 American College of Cardiology expert consensus, which recommends discharge home if there is no new AV block, no new bundle branch block, and no progression of AV block or prolongation of the QRS by ≥ 10%.[38] We have, therefore, adapted these 2 criteria for the assessment of fitness to drive because the risk of SCI was < 1% within the first year in several major contemporary randomized controlled trials and registries.[36],[39][41]

Aortic regurgitation

Aortic regurgitation is associated with HF and left ventricular dysfunction. Severe HF symptoms, NYHA class IV, are associated with a significant increase in mortality, therefore private driving should be restricted in this population. Because the rates of sudden death, and therefore SCI, have not been reported in patients with aortic regurgitation, commercial driving should only be recommended for those who are asymptomatic with preserved left ventricular function as per expert consensus.

Mitral stenosis

The natural history of asymptomatic or minimally symptomatic mitral stenosis is favourable (> 80% survival at 10 years). Globally, rheumatic mitral valve disease is an important cause of mitral stenosis and subsequent HF.[34] Mortality is usually due to progressive HF, systemic embolism related to concomitant atrial fibrillation, or pulmonary hypertension. SCD in the absence of severe symptoms is rare. For commercial driving, the development of symptoms, pulmonary hypertension, or systemic embolism might result in limitations associated with tasks related to commercial driving.[42]

Mitral and tricuspid regurgitation

Mitral and tricuspid regurgitation might be associated with atrial arrhythmias and HF symptoms. In particular, patients with severe mitral regurgitation in the setting of a flail mitral valve leaflet are also known to be at risk of SCD. Risk factors in these patients include severe symptoms, reduced left ventricular systolic function, and atrial fibrillation.[43] The presence of NYHA class IV HF symptoms is associated with increased risk of mortality and SCD, therefore private driving should be restricted in this population of patients with mitral and tricuspid regurgitation. Commercial driving should only be recommended for those who are asymptomatic with preserved left ventricular function.[44]

Sex-specific recommendations

None of the studies reviewed stratified SCI or SCD according to sex, and therefore no sex-specific recommendations can be made. In all of the studies, most of the population were men, and there remains a paucity of studies on SCI or SCD in women with valvular heart disease.

Sternotomy-based or minimally invasive valve surgery

Although catheter-based valve procedures are increasingly prevalent among patients who require an intervention, conventional surgical procedures remain appropriate for a significant number of patients with valvular heart disease. An analysis from the SWEDEHEART data determined that death from any cardiovascular cause in their series of 33,108 patients who had undergone aortic valve replacement was 10.2% at 5 years, 23.5% at 10 years, 34.9% at 15 years, and 42.8% at 20 years.[45] Only a small proportion of these would be sudden deaths, and much of the data were derived from patients who would not be the beneficiaries of more contemporary concurrent medical therapy. Aside from the short-term implications of recovering from a sternotomy, the determinants of risk of SCI after initial recovery are functional status, conduction system integrity, and LVEF, as is the case for patients with valvular disease treated with catheter-based solutions.

Practical Tips

Patients with untreated severe symptomatic aortic valve stenosis and regurgitation (NYHA class IV) are disqualified from private driving. For commercial driving, untreated aortic stenosis must be completely asymptomatic (NYHA class I).

Patents with untreated severe symptomatic mitral valve stenosis and regurgitation and tricuspid valve regurgitation (NYHA class IV) are disqualified from private and commercial driving.

Patients who have undergone TAVR with a stable QRS duration and no high-grade AV block may resume private driving 1 month after implantation date and commercial driving 3 months after implantation date.

Unless they remain NYHA class IV, patients who undergo mitral valve or tricuspid valve transcatheter edge-to-edge repair may resume private driving 48 hours after the procedure.

References

33. Keller LS, Nuche J, Mesnier J, et al. Syncope in patients with severe aortic stenosis undergoing transcatheter aortic valve replacement. Can J Cardiol 2023;39:901-8.

34. Wei S, Miranda JJ, Mamas MA, et al. Sex differences in the etiology and burden of heart failure across country income level: analysis of 204 countries and territories 1990-2019. Eur Heart J Qual Care Clin Outcomes 2023;9:662-72.

35. Otto CM, Nishimura RA, Bonow RO, et al. 2020 ACC/AHA guideline for the management of patients with valvular heart disease: executive summary: a report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol 2021;77:450-500.

36. Mack MJ, Leon MB, Thourani VH, et al. Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients. N Engl J Med 2019;380:1695-705.

37. Butala NM, Wood DA, Li H, et al. Economics of minimalist trans-catheter aortic valve replacement: results from the 3M-TAVR economic study. Circ Cardiovasc Interv 2022;15:e012168.

38. Lilly SM, Deshmukh AJ, Epstein AE, et al. 2020 ACC expert consensus decision pathway on management of conduction disturbances in patients undergoing transcatheter aortic valve replacement: a report of the American College of Cardiology Solution Set Oversight Committee. J Am Coll Cardiol 2020;76:2391-411.

39. Leon MB, Smith CR, Mack MJ, et al. Transcatheter or surgical aortic-valve replacement in intermediate-risk patients. N Engl J Med 2016;374:1609-20.

40. Popma JJ, Deeb GM, Yakubov SJ, et al. Transcatheter aortic-valve replacement with a self-expanding valve in low-risk patients. N Engl J Med 2019;380:1706-15.

41. Carroll JD, Mack MJ, Vemulapalli S, et al. STS-ACC TVT registry of transcatheter aortic valve replacement. J Am Coll Cardiol 2020;76:2492-516.

42. Kato N, Padang R, Scott CG, Guerrero M, Pislaru SV, Pellikka PA. The natural history of severe calcific mitral stenosis. J Am Coll Cardiol 2020;75:3048-57.

43. Grigioni F, Enriquez-Sarano M, Ling LH, et al. Sudden death in mitral regurgitation due to flail leaflet. J Am Coll Cardiol 1999;34:2078-85.

44. Spitaleri G, Zamora E, Cediel G, et al. Cause of death in heart failure based on etiology: long-term cohort study of all-cause and cardiovascular mortality. J Clin Med 2022;11:784.

45. Glaser N, Persson M, Franco-Cereceda A, Sartipy U. Cause of death after surgical aortic valve replacement: SWEDEHEART observational study. J Am Heart Assoc 2021;10:e022627.

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