Impact of age and comorbidities on the effect of transcatheter versus surgical mitral valve repair on inpatient outcomes.

BACKGROUND: Transcatheter mitral valve repair (TMVR) has shown to be a safe and effective treatment option for symptomatic severe mitral regurgitation (MR) in patients who are at prohibitive surgical risk. Whether age and comorbidities impact the inpatient safety outcomes of TMVR versus surgical mitral valve repair (SMVR) is unknown. METHODS: Using the national inpatient sample, patients undergoing either elective TMVR or SMVR between 2012 and 2015 were analyzed. Logistic, generalized logistic, and linear regression were used to compare inpatient complications, discharge disposition, and length of stay (LOS). Heterogeneity in the effect of TMVR versus SMVR across Charlson comorbidity index (CCI, categorized as <2 and ≥2) and age (categorized as <75 years old and ≥75 years old) were assessed for effect modification. RESULTS: Overall, 8,716 hospitalizations were included, 7,950 (91%) SMVR and 766 (9%) TMVR. Compared with SMVR, patients undergoing TMVR were older (median age 79 vs. 62 years) and more likely to be female (45% vs. 40%) with a higher CCI score (median CCI 2 vs. 1). Despite being older with a higher comorbidity burden, patients undergoing TMVR had a lower incidence of permanent pacemaker implantation (OR 0.23, 95% CI: 0.11, 0.50), cerebrovascular accidents (OR 0.37, 95% CI: 0.15, 0.92), and major bleeding (OR 0.39, 95% CI: 0.32, 0.47). TMVR patients were also discharged 3 days earlier (CIE -3.26; 95% CI: -3.72, -2.80) and were less likely to be discharged to a skilled nursing facility (OR 0.72, 95% CI 0.55, 0.93). Additionally, the relative reduction in complications after TMVR versus SMVR was significantly higher in older (age ≥75 years) and more comorbid (CCI ≥2) patients (p for interaction <.05 for both). CONCLUSION: Patients treated with TMVR, as compared with SMVR, were older and had more comorbidities, but had a lower incidence of inpatient complications, shorter LOS, and better discharge disposition. Therefore, TMVR may be a safer option than SMVR in older patients and those with a higher burden of comorbidities.

Meta-analysis of transfemoral TAVR versus surgical aortic valve replacement.

BACKGROUND: In the recently concluded PARTNER 2 trial, TF-TAVR cohort was shown to have lower risks of death or disabling strokes as compared to SAVR, whereas the outcomes with transthoracic TAVR were comparable with SAVR. METHODS: We searched PubMed, EMBASE, Web of Science, and Google Scholar for all comparison studies between TAVR and SAVR and mortality as an outcome, irrespective of surgical risk. Randomized controlled trials and propensity-score-matched cohort studies that used a transfemoral approach exclusively or stratified results by route of access and reported data for TF-TAVR patients were eligible for inclusion. Outcomes of interest included 30-day and 1-year mortality, and 30-day complications. If significant heterogeneity was found in the random effects meta-analyses, a sensitivity analysis which individually removed each study was conducted. RESULTS: Seven studies reported results on TF-TAVR. Compared with SAVR, TF-TAVR had comparable 30-day mortality (RR 0.79, 95% CI 0.58, 1.06), 1-year mortality (RR 0.91, 95% CI 0.78, 1.08) and 30-day risk of bleeding (RR 0.70, 95% CI 0.31, 1.57). However, TF-TAVR was associated with lower 30-day risks of atrial fibrillation (RR 0.28, 95% CI 0.17, 0.45), acute kidney injury (RR 0.38, 95% CI 0.20, 0.71), and myocardial infarction (RR 0.41, 95% CI 0.23, 0.75) at a cost of higher incidences of vascular complications (RR 6.10, 95% CI 2.92, 12.73) and pacemaker implantations (RR 3.29, 95% CI 1.41, 7.65). CONCLUSIONS: TF-TAVR is associated with lower 30-day risks of myocardial infarction compared to SAVR. Further studies are required to investigate the role of myocardial injury on overall TF-TAVR outcomes.

Transcatheter Versus Surgical Aortic Valve Replacement in Patients With Lower Surgical Risk Scores: A Systematic Review and Meta-Analysis of Early Outcomes.

BACKGROUND: The results from the PARTNER 2 trial showed the feasibility of transcatheter aortic valve replacement (TAVR) in intermediate surgical risk patients. Although low risk clinical trials will take time to conclude, some data has emerged comparing TAVR with surgical aortic valve replacement (SAVR) in lower risk patients. METHODS: A Medline search was conducted using standard methodology to search for studies reporting results comparing TAVR and SAVR. Studies were included if the overall mean Society of Thoracic Surgeons Score was less than 4% (or equivalent Euroscore). A meta-analysis comparing the 30-day risk of clinical outcomes between TAVR and SAVR in the lower surgical risk population was conducted. RESULTS: A total of four studies, including one clinical trial and three propensity-matched cohort studies met the inclusion criteria. Compared to SAVR, TAVR had a lower risk of 30-day mortality (RR 0.67, 95% CI 0.41, 1.10), stroke (RR 0.60, 95% CI 0.30, 1.22), bleeding complications (RR 0.51, 95% CI 0.40, 0.67) and acute kidney injury (RR 0.66, 95% CI 0.47, 0.94). However, a higher risk of vascular complications (RR 11.72, 95% CI 3.75, 36.64), moderate or severe paravalvular leak (RR 5.04, 95% CI 3.01, 8.43), and permanent pacemaker implantations (RR 4.62, 95% CI 2.63, 8.12) was noted for TAVR. CONCLUSION: Among lower risk patients, TAVR and SAVR appear to be comparable in short term outcomes. Additional high quality studies among patients classified as low risk are needed to further explore the feasibility of TAVR in all surgical risk patients.

TAVR in Intermediate-Risk Patients: A Review of the PARTNER 2 Trial and its Future Implications.

BACKGROUND: Following publication of the results of the PARTNER trial, the American College of Cardiology/American Heart Association recognized the success of transcatheter aortic valve replacement (TAVR) by incorporating it as a feasible option in high-surgical risk patients, and recommending it as the standard of care for patients at prohibitive risk of surgery. Although this was recognized as a major success in the field of percutaneous valve replacement, surgical aortic valve replacement (SAVR) continued to be realized as the procedure of choice for low and intermediate surgical risk patients. Meanwhile, observational studies - predominantly from Europe - showed encouraging results for TAVR in lower-risk populations. With a lack of any large randomized controlled clinical trial, however, the advantages of TAVR continued to be limited to only a minority of patients with severe, symptomatic aortic stenosis. METHODS: Between December 2011 and November 2013, the PARTNER 2 investigators enrolled a total of 2,032 intermediate-risk patients with severe symptomatic aortic stenosis at 57 centers in the United States and Canada. Patients were randomized 1:1 to undergo either TAVR or SAVR. The primary end point was death and neurological events after two years. RESULTS: The study results showed similar rates for death and neurological events in the TAVR and SAVR groups. The TAVR group was found to have a larger valve area and a lower incidence of acute kidney injury, bleeding events, and atrial fibrillation. Conversely, the SAVR group experienced fewer vascular complications and lower rates of paravalvular regurgitation. CONCLUSIONS: The results of the PARTNER 2 trial are reviewed, and its implications for the future discussed.

Transcatheter Mitral Valve-in-Ring for Progressive Mitral Stenosis after Prior Repair with Annuloplasty: A Novel Balloon Sizing Technique.

An 83-year-old man with a previous mitral valve repair using a semi-rigid annuloplasty ring was found to have severe mitral stenosis. A transcatheter approach for mitral valve-in-ring replacement was selected due to the patient's high surgical risk. Pre-procedural computed tomography scans for transcatheter valve size selection were inconsistent with previously published recommendations. To determine the appropriate valve size, a 25 mm compliant balloon was inflated intraoperatively within the stenotic mitral ring, but yielded no resistance to movement and no 'waist'. Thus, a 29 mm balloon-expandable prosthetic valve was selected and deployed with no paravalvular leak. This novel balloon sizing technique helped lead to a successful outcome in this case. Video 1: Angiographic video displaying mitral valve-in-ring balloon sizing technique. The 25 mm compliant balloon was inflated within a stenotic mitral ring to determine which prosthetic transcatheter valve size was appropriate. As shown, this technique yielded no 'waist' and no resistance to movement, suggesting that a 29 mm valve was necessary.

A machine learning model in predicting hemodynamically significant coronary artery disease: A prospective cohort study.

Background: Coronary artery disease (CAD) costs healthcare billions of dollars annually and is the leading cause of death despite available noninvasive diagnostic tools. Objective: This study aims to examine the usefulness of machine learning in predicting hemodynamically significant CAD using routine demographics, clinical factors, and laboratory data. Methods: Consecutive patients undergoing cardiac catheterization between March 17, 2015, and July 15, 2016, at UNC Chapel Hill were screened for comorbidities and CAD risk factors. In this pilot, single-center, prospective cohort study, patients were screened and selected for moderate CAD risk (n = 185). Invasive coronary angiography and CAD prediction with machine learning were independently performed. Results were blinded from operators and patients. Outcomes were followed up for up to 90 days for major adverse cardiovascular and renal events (MACREs). Greater than 70% stenosis or a fractional flow reserve less than or equal to 0.8 represented hemodynamically significant coronary disease. A random forest model using demographic, comorbidities, risk factors, and lab data was trained to predict CAD severity. The Random Forest Model predictive accuracy was assessed by area under the receiver operating characteristic curve with comparison to the final diagnoses made from coronary angiography. Results: Hemodynamically significant CAD was predicted by 18-point clinical data input with a sensitivity of 81% ± 7.8%, and specificity of 61% ± 14.4% by the established model. The best machine learning model predicted a 90-day MACRE with specificity of 44.61% ± 14.39%, and sensitivity of 57.13% ± 18.70%. Conclusion: Machine learning models based on routine demographics, clinical factors, and lab data can be used to predict hemodynamically significant CAD with accuracy that approximates current noninvasive functional modalities.

The Prevalence and Impact of Atrial Fibrillation on 1-Year Outcomes in Patients Undergoing Transcatheter Mitral Valve Repair: Results From the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry.

OBJECTIVES: The aim of this study was to compare 1-year outcomes following transcatheter mitral valve (MV) repair in patients with and without atrial fibrillation (AF). BACKGROUND: The development of AF in degenerative mitral regurgitation (MR) is considered a sign of MR progression and is associated with adverse clinical events. However, the impact of AF in patients undergoing transcatheter MV repair remains uncertain. METHODS: The TVT (Transcatheter Valve Therapy) Registry was used to identify patients undergoing transcatheter MV repair with the MitraClip between November 2013 and June 2016. Using Centers for Medicare and Medicaid Services-linked data, the 1-year rate of death, heart failure hospitalization, stroke, and bleeding following transcatheter MV repair was compared in patients with and without AF. Outcomes were analyzed using multivariate Cox regression modeling. RESULTS: A total of 5,613 patients underwent commercial transcatheter MV repair in the United States during the study period, including 3,555 (63%) with pre-existing AF. Compared with patients without AF, patients with AF were older, were more likely to be male and Caucasian, had more comorbidities, and had higher Society of Thoracic Surgeons Predicted Risk of Mortality scores (median 7% vs. 5%; p < 0.0001). Acute procedural success (post-procedural ≥2+ MR, 37.4% vs. 35.0%; p = 0.20) and in-hospital mortality were similar, but length of hospital stay was longer for patients with AF (mean 4.91 days vs. 4.37 days; p = 0.0004). A total of 3,261 patients were linked to Centers for Medicare and Medicaid Services claims data. After adjustment, patients with AF had a higher 1-year rate of death or HF (hazard ratio [HR]: 1.27; 95% confidence interval [CI]: 1.11 to 1.44; p < 0.001). Patients with AF had higher rates of mortality (HR: 1.44; 95% CI: 1.22 to 1.70; p < 0.001), HF hospitalization (HR: 1.17; 95% CI: 1.00 to 1.36; p = 0.05), stroke (HR: 1.63; 95% CI: 1.01 to 2.64; p = 0.047), and bleeding (HR: 1.34; 95% CI: 1.10 to 1.64; p = 0.004) at 1 year as well. Among those with AF, the risk for stroke was lower (HR: 0.55; 95% CI: 0.32 to 0.93; p = 0.026) among those on anticoagulation. CONCLUSIONS: In patients undergoing transcatheter MV repair, AF is common and is associated with worse clinical outcomes at 1 year despite similar acute procedural success. Further study is needed to investigate if early treatment of MR reduces the future risk for developing AF and to identify therapies that improve outcomes in these patients.

In-Hospital Outcomes After Transcatheter Versus Surgical Aortic Valve Replacement in Octogenarians.

Background Octogenarians have low physiologic reserve and may benefit more from transcatheter aortic valve replacement ( TAVR ) than surgical aortic valve replacement ( SAVR ). Methods and Results This retrospective cohort study based on the National Inpatient Sample included octogenarians who underwent TAVR or SAVR from 2012 to 2015. Crude and standardized-morbidity-ratio-weighted regression models were used to compare in-hospital outcomes. Among 19 145 TAVR and 9815 SAVR hospitalizations, TAVR patients had higher Charlson Comorbidity Index ( CCI ) scores (2.0 versus 0.8, P<0.0001) than SAVR patients. Before weighting, TAVR was associated with significantly shorter length of stay, more home discharges, and lower incidences of acute kidney injury, bleeding, and cardiogenic shock. Associations were consistent across Charlson Comorbidity Index, except for TAVR being associated with greater length of stay reductions among patients with Charlson Comorbidity Index ≥2, compared with Charlson Comorbidity Index <2 (change in estimate -3.56 versus -2.61 days, P=0.004). After weighting, TAVR patients had significantly shorter length of stay (change in estimate -3.29 days, 95% CI -3.82, -2.75) and lower odds of transfer to skilled nursing facility (odds ratio 0.34, 95% CI 0.29, 0.41), acute kidney injury (odds ratio 0.55, 95% CI 0.45, 0.68), bleeding (odds ratio 0.44, 95% CI 0.37, 0.53), and cardiogenic shock (odds ratio 0.55, 95% CI 0.33, 0.92), compared with SAVR patients. Odds of permanent pacemaker implantation, transient ischemic attack/stroke, vascular complications, and in-hospital mortality were not significantly different. Conclusions TAVR may be preferred over SAVR in high-risk octogenarians because of shorter length of stay, better discharge disposition, and less acute kidney injury, and bleeding. All octogenarians may benefit more from TAVR , irrespective of comorbidity burden, but additional research is needed to confirm our findings.

Length of Stay and Discharge Disposition After Transcatheter Versus Surgical Aortic Valve Replacement in the United States.

BACKGROUND: As transcatheter aortic valve replacement (TAVR) extends its reach to lower surgical risk patients, the differences between resource utilization for TAVR and surgical AVR (SAVR) will become increasingly important. METHODS AND RESULTS: AVR procedures between January 2012 and September 2015 at hospitals performing TAVR were identified using the National Inpatient Sample databases. Adults aged ≥50 years with aortic stenosis who underwent isolated TAVR or SAVR were eligible for inclusion. Standardized morbidity ratio weights were calculated using patient demographics, comorbidities, and hospital characteristics. Weighted linear and generalized logistic regression models were used to estimate the effect of undergoing TAVR, compared with undergoing SAVR, on length of stay (LOS) and discharge disposition. In TAVR-performing hospitals, 7266 (40%) patients underwent TAVR (6107 endovascular approach and 1159 transapical approach), while 10 833 (60%) underwent isolated SAVR. Patients undergoing TAVR were older, more likely to be female, and had more comorbidities. From 2012 to 2015, average LOS declined for both TAVR (6.3 days to 4.6 days; P<0.0001) and SAVR (7.5 days to 6.8 days; P<0.0001), with greater reduction in the TAVR group ( P<0.0001). An increase in home/home health discharge was noted with TAVR (67.7%-77.4%; P<0.0001) but not with SAVR (76.8%-79.5%; P=0.25). After standardizing, patients undergoing TAVR had significantly shorter LOS (change in estimate, -2.93, 95% CI, -3.26 to -2.60) and lower incidence of transfer to skilled nursing facility (odds ratio, 0.45; 95% CI, 0.40-0.51) but no difference in in-hospital mortality (odds ratio, 0.85; 95% CI, 0.61-1.20) compared with if they had undergone SAVR. As compared with SAVR, patients who had TAVR performed via an endovascular approach had shorter LOS and lower rates of skilled nursing facility transfer, whereas in the transapical cohort, LOS, and skilled nursing facility transfer were similar to SAVR. CONCLUSIONS: As compared with if they undergo SAVR, patients undergoing TAVR (by a nontransapical approach) had a shorter LOS and higher likelihood of home discharge, as opposed to skilled nursing facility. From 2012 to 2015, there was a greater trend towards a reduction of LOS and more home discharges among TAVR, as opposed to SAVR. These data have important implications in the era of constrained resources with a growing emphasis on reducing health care costs.

Evaluating Health of Emerging Economies Through the Eyes of Heart Valve Disease in the Transcatheter Era.

China and India are the 2 fastest growing major world economies. However, they suffer from great differences in health policies, demographics, and rates of population growth. Whereas China has seen a steep decline in rheumatic heart disease (RHD) and a rise in life expectancy, India continues to suffer from a significant burden of RHD due to insufficient distribution of economic prosperity to health care, denser population, and ineffective application of World Health Organization RHD prevention guidelines. As China faces the burden of the world's largest geriatric population, focus has shifted to calcific aortic stenosis for which it prepares by expansions in the field of transcatheter aortic valve replacement. Conversely, India has a younger population and a lower average life expectancy. Therefore, focus in India has still not shifted to calcific aortic stenosis as a major cause of morbidity and mortality as RHD continues to constitute the bulk of valvular heart disease.

Review of Major Registries and Clinical Trials of Late Outcomes After Transcatheter Aortic Valve Replacement.

The results of the Placement of AoRtic TraNscathetER Valves (PARTNER) 2 trial established the feasibility of transcatheter aortic valve replacement (TAVR) for intermediate surgical risk patients. The expansion of TAVR into the low-risk patient population will largely depend on its durability outcomes due to the high life expectancy in low-risk patients. Long-term follow-up results from low-risk clinical trials will take several years to be reported. Given this, we performed a systematic review of current long-term data to provide further insights into TAVR durability and long-term patient survival. We searched MEDLINE, Embase, Google Scholar, BIOSIS, and major conference abstracts for TAVR studies with follow-up of at least 4 years. Abstracts were retrieved and independently reviewed for eligibility. Final studies were selected irrespective of the type of TAVR valve, route of vascular access, or surgical risk profile. A total of 12 studies met the inclusion criteria. We reviewed data from these studies with emphasis on long-term survival and echocardiographic findings.

Transcatheter versus surgical aortic valve replacement in intermediate risk patients: a meta-analysis.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) has been approved in patients with high or prohibited surgical risk for surgery for treatment of severe symptomatic aortic stenosis. Prospective studies examining the benefits of TAVR in intermediate risk patients are ongoing. Other smaller studies including lower risk patients have been conducted, but further meta-analysis of these studies is required to draw more broad comparisons. METHODS: A Medline search was conducted using standard methodology to search for clinical trials and observational studies including intermediate risk patients. We limited our meta-analysis to studies matching patient populations by propensity scores or randomization and examined clinical outcomes between TAVR and surgical aortic valve replacement (SAVR). RESULTS: Analysis of the TAVR and SAVR cohorts revealed no significant differences in the outcomes of 30-day [OR (95% CI): 0.85 (0.57, 1.26)] or 1-year mortality [OR (95% CI): 0.96 (0.75, 1.23)]. A trend towards benefit with TAVR was noted in terms of neurological events and myocardial infarction (MI) without statistical significance. A statistically significant decrease in risk of post-procedural acute renal failure in the TAVR group [OR (95% CI): 0.52 (0.27, 0.99)] was observed, but so was a significantly higher rate of pacemaker implantations for the TAVR group [OR (95% CI): 6.51 (3.23, 13.12)]. CONCLUSIONS: We conclude that in intermediate risk patients undergoing aortic valve replacement, the risk of mortality, neurological outcomes, and MI do not appear to be significantly different between TAVR and SAVR. However, there appears to be a significant reduction in risk of acute renal failure at the expense of an increased risk of requiring a permanent pacemaker in low and intermediate risk patients undergoing TAVR compared to SAVR.

Application of a Multidisciplinary Enhanced Recovery After Surgery Pathway to Improve Patient Outcomes After Transcatheter Aortic Valve Implantation.

Enhanced recovery after surgery (ERAS) protocols have proven effective in a variety of surgical specialties. Published reports on these pathways within cardiac surgery and interventional cardiology are limited. Invasive aortic valve replacement procedures are increasingly being performed by hybrid groups of interventional cardiologists and surgeons through transcatheter aortic valve implantation (TAVI). The TAVI patient population is at a higher surgical risk compared with those undergoing surgical aortic valve replacement since they are older, frailer, and have significant co-morbidities which result in an increased risk of perioperative complications. ERAS protocols have the potential to help these patients undergoing TAVI procedures. In conclusion, we propose a TAVI ERAS protocol with a call-to-action for other centers to implement an ERAS protocol to improve hospital and cardiac outcomes.