Outcomes of procedural complications in transfemoral transcatheter aortic valve replacement.

OBJECTIVES: As the application of transcatheter aortic valve replacement (TAVR) expands, the longitudinal implications of periprocedural complications are increasingly relevant. We examine the influence of TAVR complications on midterm survival. METHODS: Patients undergoing transfemoral TAVR at our institution between November 2011 and June 2018 were reviewed. Stroke severity was classified according to the National Institutes of Health stroke score. Kaplan-Meier analysis was used to assess survival, and a Cox proportional hazards model was created to examine independent associations with survival. The median follow-up time was 36 months for a total of 2789 patient-years. RESULTS: Overall, 866 patients were included. The mean age was 80 ± 9.5 years and mean Society of Thoracic Surgeons score was 4.8% ± 2.7%. The mortality rate at 30-days was 2.8% and 11.8% at 1 year. In-hospital left bundle branch block and 30-day permanent pacemaker insertion occurred in 14.8% and 7.9%, respectively. Postprocedural greater-than-mild paravalvular leak was present in 4.4% and stroke occurred in 3.8% at 30-days. Greater-than-mild paravalvular leak was associated with decreased survival at 2 years (P = .02), but not at 5 years. Severe stroke was independently associated with decreased survival at 5 years (hazard ratio, 5.73; 95% confidence interval, 2.29-14.36; P ≤ .001); however, the effect of nonsevere stroke did not reach significance (hazard ratio, 1.69; 95% confidence interval, 0.82-3.47; P = .152). CONCLUSIONS: Severe stroke was independently associated with decreased 5-year survival and initial risks associated with paravalvular leak may be attenuated over the midterm following transfemoral TAVR. Strategies to minimize the incidence of stroke and paravalvular leak must be prioritized to improve longitudinal outcomes after TAVR.

Postdischarge Pain and Opioid Use After Cardiac Surgery: A Prospective Cohort Study.

BACKGROUND: The rate of chronic opioid use after cardiac surgery is high compared with other surgical specialties; however evidence regarding optimal prescribing is limited. The purpose of this study was to evaluate patterns of opioid consumption after cardiac surgery to guide prescribing practices. METHODS: Consecutive patients undergoing sternotomy-based cardiac operations were considered for enrollment. Patients with opioid use within 3 months of surgery and those discharged to a nonhome facility were excluded. A patient diary and researcher-directed pill count was used to track pain and opioid use for 10 days after discharge. RESULTS: One hundred four patients were included in the final analysis. Of the 63 patients discharged with an opioid, 22 (34.9%) used none and 12 (19.0%) used fewer than half of the pills prescribed. Overall, pain and opioid consumption decreased significantly throughout the discharge period (P < .001). In those who used opioids after discharge, median total consumption was 64 morphine milligram equivalents (interquartile range, 38-128), or the equivalent of 9 oxycodone 5-mg tablets. Patients who used opioids were younger (60.9 vs 70.0, P < .001), but there were no differences based on sex, history of substance use, smoking, or procedure. After risk adjustment the mean pain score ≥ 3 on the day of discharge was predictive of opioid use (odds ratio, 2.9; 95% confidence interval, 1.8-4.8; P < .001). Most patients (88.5%) were satisfied or very satisfied with pain management. CONCLUSIONS: Fewer than half of all patients used opioids after discharge in this study. These data support the need for the development of prescription recommendations after cardiac surgery.

All-cause procedural readmissions following transcatheter aortic valve replacement.

Objective: With expanding eligibility criteria, transcatheter aortic valve replacement is being performed on patients with longer life expectancy, and subsequent procedures after index transcatheter aortic valve replacement are inevitable. This study examines the incidence and outcomes of patients undergoing subsequent procedural readmissions after transcatheter aortic valve replacement. Methods: All patients who underwent index transcatheter aortic valve replacement and were discharged alive from January 2012 to December 2019 at a single institution were evaluated. Study end points were mortality and readmission for procedure with more than 1-day hospital stay. Effect on survival was evaluated by treating procedural readmission as a time-dependent variable by Cox proportional hazard model and competing risk analysis. Results: A total of 1092 patients met inclusion criteria with a median follow-up time of 34 months. A total of 218 patients (20.0%) had 244 subsequent procedural readmissions. During the 244 procedural readmissions, there were 260 procedures; 96 (36.9%) were cardiac (most commonly pacemaker implantation, percutaneous coronary interventions, and surgical aortic valve replacements), and 164 (63.1%) were noncardiac (most commonly orthopedic and gastrointestinal procedures). The overall procedural readmission rates were 32%, 39%, and 42%, and all-cause mortality was 27%, 44%, and 54% at 20, 40, and 60 months, respectively. Procedural readmissions were not associated with a survival penalty in any surgical risk group or on Cox regression (hazard ratio, 1.25; 0.91-1.64, P = .17). Conclusions: After transcatheter aortic valve replacement, procedural interventions are seen frequently, with most procedures occurring within the first year after transcatheter aortic valve replacement. However, subsequent procedural readmissions do not appear to have a survival penalty for patients after transcatheter aortic valve replacement. After transcatheter aortic valve replacement with resolution of aortic stenosis, subsequent procedures can and should be pursued if they are needed.

Observed versus expected morbidity and mortality in patients undergoing mitral valve repair.

OBJECTIVES: Mitral valve repair (MVP) is the gold standard treatment for degenerative mitral regurgitation. With the expansion of transcatheter technologies, this study compares the outcome of MVP in low-risk and non-low-risk patients to serve as a benchmark. METHODS: This retrospective, single-institution study examined all patients who underwent MVP for primary mitral regurgitation from 2005 to 2018. Patients were stratified into 2 risk categories: low-risk [Society of Thoracic Surgeons (STS) Predicted Risk of Mortality (STS-PROM) ≤2%] and non-low risk (STS-PROM > 2% or age > 75), with a subgroup of very low risk (STS-PROM ≤1%, age <75). RESULTS: A total of 1207 patients were included, and 1053 patients were classified as low risk and 154 as non-low risk. The non-low-risk group was significantly older, more likely to be female, and had a higher comorbidity burden than the low-risk group (all P < 0.01). For the low-risk group, the observed-to-expected (O:E) STS mortality ratio was 0.4 and the composite morbidity and mortality ratio was 0.6, whereas for the non-low risk, the O:E mortality was 1.5 and the composite morbidity and mortality was 0.9. When the subgroup of very low-risk group was assessed, the mortality O:E ratio was 0. CONCLUSIONS: The observed composite morbidity and mortality of patients undergoing MVP were persistently lower in low-risk patients, mainly driven by the very low-risk group. The excellent outcome of MVP in low-risk patients should be validated on a national level to determine how transcatheter technologies can be utilized in these patients.

Subclinical Structural Valve Degeneration in Young Patients With Bioprosthetic Aortic Valves.

BACKGROUND: Bioprosthetic structural valve degeneration (SVD) has previously been a clinical diagnosis, but subclinical changes have been increasingly recognized in transcatheter valves. The significance of subclinical SVD after surgical aortic valve replacement (SAVR), however, is not well understood. The purpose of this study was to characterize the incidence and outcomes of subclinical SVD in young patients after SAVR. METHODS: Patients aged ≤65 years who underwent bioprosthetic SAVR between January 2002 and June 2018 at a single institution were included. Endocarditis cases and those with in-hospital mortality were excluded. All available longitudinal postoperative echocardiograms were reviewed. Subclinical SVD was defined as an increase in mean transvalvular gradient of at least 10 mm Hg and/or new onset of mild intraprosthetic regurgitation or increase by at least 1 grade, compared with baseline postoperative echocardiogram. RESULTS: Overall, 822 unique SAVR cases were included. Over the study period, 356 (43.3%) patients developed subclinical SVD. Only 21.5% of those with subclinical SVD progressed to clinical SVD or to repeat aortic valve procedures. In those with progression, the first signs of SVD occurred significantly earlier than in those whose changes remained stable (11 months vs 23 months; P = .036). Anticoagulation did not impact the development or progression of subclinical SVD. There was no difference in long-term survival for those who did or did not develop subclinical SVD. CONCLUSIONS: Subclinical SVD occurred in a large proportion of young patients undergoing bioprosthetic SAVR. Despite its high prevalence, subclinical SVD was not associated with decreased survival or repeat procedures.

Long-term Outcomes of Aortic Valve Replacement With Aortic Homograft: 27 Years Experience.

BACKGROUND: Aortic homografts have been used in young patients requiring aortic valve replacement. Currently, these grafts are generally reserved for aortic valve endocarditis with or without root abscess; however, longitudinal data are lacking. Our aim was to assess the long-term safety and durability of homograft implantation. METHODS: All adult patients undergoing aortic homograft implantation at a single institution from 1992 to 2019 were included. Outcomes of interest included all-cause mortality and aortic valve reoperation, studied over a median follow-up duration of 19 years. RESULTS: In all, 252 patients with a mean age of 49 years were included. Infective endocarditis was the primary indication for surgery in 95 patients (38%). The endocarditis group, compared with the no-endocarditis group, had a higher prevalence of New York Heart Association class III-IV (56% vs 26%), chronic kidney disease (22% vs 1%), prior cardiac surgery (40% vs 10%), and emergency status (7% vs 0%; all P < .001). Operative mortality was higher among endocarditis patients (16% vs 0.6%, P < .001), which persisted after risk adjustment. Among patients who survived to discharge, however, there was no difference in long-term survival between the endocarditis group and no-endocarditis group. Overall survival and freedom from reoperation were 88.3% and 80% at 15 years and 87.2% and 78% at 25 years, respectively. Indications for reoperation included structural valve deterioration (83%), endocarditis (12%), and mitral valve disease (5%). Reoperative mortality occurred in 2 patients (4.9%). CONCLUSIONS: Aortic homografts are associated with good long-term survival and admissible freedom from reoperation. Operative mortality is high among patients with endocarditis; however, for those who survive to discharge, long-term survival and durability are the same as for patients without endocarditis.

Should Health Numeracy Be Assessed Objectively or Subjectively?

INTRODUCTION: Because current evidence suggests that numeracy affects how people make decisions, it is an important factor to account for in studies assessing the effectiveness of medical decision support interventions. Subjective and objective numeracy assessment methods are available that vary in theoretical background, skills assessed, known relationship with decision making skills, and ease of implementation. The best way to use these tools to assess numeracy when conducting medical decision-making research is currently unknown. METHODS: We conducted Internet surveys comparing numeracy assessments obtained using the subjective numeracy scale (SNS) and 5 objective numeracy scales. Each study participant completed the SNS and 1 objective numeracy measure. Following each assessment, participants indicated willingness to repeat the assessment and rated its user acceptability. RESULTS: The overall response rate was 78%, resulting in a total sample size of 673. Spearman correlations between the SNS and the objective numeracy measures ranged from 0.19 to 0.44. Acceptability assessments for the short form of the Numeracy Understanding in Medicine Instrument and the SNS did not differ significantly. The other objective scales all had lower acceptability ratings than the SNS. CONCLUSIONS: These findings are consistent with prior research suggesting that objective and subjective numeracy scales measure related but distinct constructs. Due to current uncertainty regarding which construct is more likely to influence the effectiveness of decision support interventions, these findings warrant further investigation to determine the proper use of objective versus subjective numeracy assessments in medical decision-making research. Pending additional information, a reasonable approach is to measure both objective and subjective numeracy so that the full range of actual and perceived numeracy skills can be taken into account.

Decision Aids: The Effect of Labeling Options on Patient Choices and Decision Making.

BACKGROUND: Conscious and unconscious biases can influence how people interpret new information and make decisions. Current standards for creating decision aids, however, do not address this issue. METHOD: Using a 2×2 factorial design, we developed surveys that contained a decision scenario (involving a choice between aspirin or a statin drug to lower risk of heart attack) and a decision aid. Each aid presented identical information about reduction in heart attack risk and likelihood of a major side effect. They differed in whether the options were labeled and the amount of decisional guidance: information only (a balance sheet) versus information plus values clarification (a multicriteria decision analysis). We sent the surveys to members of 2 Internet survey panels. After using the decision aid, participants indicated their preferred medication. Those using a multicriteria decision aid also judged differences in the comparative outcome data provided for the 2 options and the relative importance of achieving benefits versus avoiding risks in making the decision. RESULTS: The study sample size was 536. Participants using decision aids with unlabeled options were more likely to choose a statin: 56% versus 25% (P < 0.001). The type of decision aid made no difference. This effect persisted after adjustment for differences in survey company, age, gender, education level, health literacy, and numeracy. Participants using unlabeled decision aids were also more likely to interpret the data presented as favoring a statin with regard to both treatment benefits and risk of side effects (P ≤ 0.01). There were no significant differences in decision priorities (P = 0.21). CONCLUSION: Identifying the options in patient decision aids can influence patient preferences and change how they interpret comparative outcome data.