Incidence, characteristics, and outcomes of reintervention after mitral transcatheter edge-to-edge repair.

OBJECTIVE: The use of transcatheter edge-to-edge repair (TEER) is growing substantially, and reintervention after TEER by way of repeat TEER or mitral valve surgery (MVS) is increasing as a result. In this nationally representative study we examined the incidence, characteristics, and outcomes of reintervention after index TEER. METHODS: Between July 2013 and November 2017, we reviewed 11,396 patients who underwent index TEER using Medicare beneficiary data. These patients were prospectively tracked and identified as having repeat TEER or MVS. Primary outcomes included 30-day mortality, 30-day readmission, 30-day composite morbidity, and cumulative survival. RESULTS: Among 11,396 patients who underwent TEER, 548 patients (4.8%) required reintervention after a median time interval of 4.5 months. Overall 30-day mortality was 8.6%, 30-day readmission was 20.9%, and 30-day composite morbidity was 48.2%. According to reintervention type, 294 (53.7%) patients underwent repeat TEER, and 254 (46.3%) underwent MVS. Patients who underwent MVS were more likely to be younger and female, but had a similar comorbidity burden compared with the repeat TEER cohort. After adjustment, there were no differences in 30-day mortality (adjusted odds ratio [AOR], 1.26 [95% CI, 0.65-2.45]) or 30-day readmission (AOR, 1.14 [95% CI, 0.72-1.81]). MVS was associated with higher 30-day morbidity (AOR, 4.76 [95% CI, 3.17-7.14]) compared with repeat TEER. Requirement for reintervention was an independent risk factor for long-term mortality in a Cox proportional hazard model (hazard ratio, 3.26 [95% CI, 2.53-4.20]). CONCLUSIONS: Reintervention after index TEER is a high-risk procedure that carries a significant mortality burden. This highlights the importance of ensuring procedural success for index TEER to avoid the morbidity of reintervention altogether.

The Effect of Adding Procalcitonin to the Systemic Inflammatory Response Syndrome (Sirs) and Quick Sepsis-Related Organ Failure Assessment (qSOFA) Scoring System in Predicting Sepsis Mortality.

OBJECTIVE:  The primary objective of this study was to determine if the addition of procalcitonin to the existing systemic inflammatory response syndrome (SIRS) and quick Sepsis-related Organ Failure Assessment (qSOFA) scoring systems could improve the predictability of in-hospital sepsis-related mortality. Secondarily, we sought to determine if the addition of procalcitonin could predict the likelihood of ICU admission and discharge home. DESIGN: This is a retrospective, single-center, observational study that looked at data from January 1, 2017 to January 1, 2019. Patients were stratified into four groups: SIRS-positive + procalcitonin >2 ng/mL (pSIRS+), SIRS-positive + procalcitonin ≤2 ng/mL (pSIRS-), qSOFA-positive + procalcitonin >2 ng/mL (pqSOFA+), and qSOFA-positive + procalcitonin ≤2 ng/mL (pqSOFA-). SETTING: The study was conducted at a community hospital in Las Vegas, Nevada. PATIENTS: Patients were included in the study if they were >18 years of age and had hospital admission diagnosis of sepsis with at least one value of procalcitonin level. INTERVENTIONS: After patients which met the inclusion criteria, patients were divided into subgroups of SIRS, SIRS + procalcitonin > 2 ng/mL, qSOFA, qSOFA + procalcitonin >2 ng/mL. Primary outcomes were in-hospital mortality and secondary outcomes were ICU admission, length of stay, and discharge to home. RESULTS:  933 patients were included in the study with an overall mortality rate of 21.22%, an overall ICU admission rate of 56.15%, and an overall discharge home rate of 29.58%. In those identified with a sepsis-related diagnosis code, pSIRS+ predicted an in-hospital mortality rate of 31.89% compared to pSIRS- 16.15% (P < 0.0001). In regards to qSOFA, the addition of procalcitonin added no statistically significant difference in predicting in-hospital mortality. pSIRS+ patients were found to have an ICU admission rate of 76.16% and a discharge home rate of 19.20% compared to pSIRS- who had 47.40% and 34.90%, respectively (P < 0.0001). Like in our primary outcome, our data for qSOFA was not statistically significant. CONCLUSIONS:  Procalcitonin added utility to the SIRS scoring system in predicting sepsis-related in-hospital mortality, ICU admission, and discharge home. Procalcitonin did not add statistically significant benefit to the qSOFA scoring system in predicting sepsis-related in-hospital mortality, ICU admission, and discharge home.

Association Between Peripheral Versus Central Access for Alternative Access Transcatheter Aortic Valve Replacement and Mortality and Stroke: A Report From the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry.

BACKGROUND: In some patients, the alternative access route for transcatheter aortic valve replacement (TAVR) is utilized because the conventional transfemoral approach is not felt to be either feasible or optimal. However, accurate prognostication of patient risks is not well established. This study examines the associations between peripheral (transsubclavian/transaxillary, and transcarotid) versus central access (transapical and transaortic) in alternative access TAVR and 30-day and 1-year end points of mortality and stroke for all valve platforms. METHODS: Using data from The Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry with linkage to Medicare claims, patients who underwent alternative access TAVR from June 1, 2015 to June 30, 2018 were identified. Adjusted and unadjusted Cox proportional hazards modeling were performed to determine the association between alternate access TAVR site and 30-day and 1-year end points of mortality and stroke. RESULTS: Of 7187 alternative access TAVR patients, 3725 (52%) had peripheral access and 3462 (48%) had central access. All-cause mortality was significantly lower in peripheral access versus central access group at in-hospital and 1 year (2.9% versus 6.3% and 20.3% versus 26.6%, respectively), but stroke rates were higher (5.0% versus 2.8% and 7.3% versus 5.5%, respectively; all P<0.001). These results persisted after 1-year adjustment (death adjusted hazard ratio, 0.72 [95% CI, 0.62-0.85] and stroke adjusted hazard ratio, 2.92 [95% CI, 2.21-3.85]). When broken down by individual subtypes, compared with transaxillary/subclavian access patients, transapical, and transaortic access patients had higher all-cause mortality but less stroke (P<0.05). CONCLUSIONS: In this real-world, contemporary, nationally representative benchmarking study of alternate access TAVR sites, peripheral access was associated with favorable mortality and morbidity outcomes compared with central access, at the expense of higher stroke. These findings may allow for accurate prognostication of risk for patient counseling and decision-making for the heart team with regard to alternative access TAVR.

Nationally Representative Repeat Transcatheter Aortic Valve Replacement Outcomes: Report From the Centers for Medicare and Medicaid Services.

OBJECTIVES: The aim of this study was to examine real-world experience with repeat transcatheter aortic valve replacement (TAVR) in a population-based national database. BACKGROUND: Repeat TAVR is a growing option in patients requiring reintervention for TAVR. However, large-scale studies with longitudinal follow-up are limited. METHODS: All Medicare beneficiaries who underwent TAVR from 2012 to 2017 were included. Outcomes included 30-day and longitudinal mortality and major adverse cardiovascular events, defined as death, stroke, pacemaker insertion, major bleeding, acute kidney injury, or cardiac arrest. Outcomes of repeat TAVR were compared with surgical explantation after TAVR (TAVR explantation) in a matched analysis. RESULTS: Of 133,250 patients who underwent TAVR, 617 (0.46%) underwent subsequent repeat TAVR at a median interval of 154 days (interquartile range: 58-537 days). Mortality at 30 days and 1 year was 6.0% and 22.0%, respectively. Rates of 30-day stroke and pacemaker insertion were 1.8% and 4.2%. Mortality at 30 days was lower in those who underwent their first TAVR during the later era (2015-2017) compared with earlier years (2012-2014) (4.6% vs 8.7%; P = 0.049). Repeat TAVR was associated with lower 30-day mortality compared with a matched group undergoing TAVR explantation (6.2% vs 12.3%; P = 0.05), although 1-year mortality was similar (21.0% vs 20.8%; P = 1.000). The incidence of 30-day major adverse cardiovascular events was higher with TAVR explantation compared with repeat TAVR (risk ratio: 2.92; 95% CI: 1.88-4.99; P ≤ 0.001). CONCLUSIONS: Repeat TAVR was performed with acceptable 30-day mortality in this high-risk population. Short-term outcomes were superior to surgical explantation, but 1-year outcomes were similar. Repeat TAVR will likely be an important option for aortic valve reintervention after TAVR.

The case for a qualitative lesion assessment system for coronary angiography.

Since the advent of coronary angiography, the standard for reporting of coronary lesion severity has been to utilize percent diameter stenosis (%DS). Given the imperfections of %DS as well as the widespread availability of intraprocedural intracoronary imaging and physiology assessment, it is time to consider a simpler yet more clinically relevant lesion assessment system. We compiled ten actual cases and presented these cases to 10 operators, providing 100 independent lesion assessments. For each case, operators were asked to describe lesions using %DS and a simplified lesion assessment system. We assessed the relationship between %DS and qualitative lesion assessment as well as the relationship of both measurements to the chosen plan. Greater variability exists with %DS than with qualitative lesion assessment. Despite this, there is good correlation between %DS and the qualitative lesion assessment (ρ = 0.8221). There remains overlap of lesion assessment using the qualitative lesion assessment tool suggesting that even with this simpler tool, there remains interobserver variability (ICC = 0.5164, 95% confidence interval [CI] 0.2924-0.7955). When assessing how both lesion assessment, there appears to be a stronger correlation between the qualitative lesion assessment and the chosen plan versus the %DS and the chosen plan (ρ = 0.9069 vs ρ = 0.8001, P < .01). Given the superior performance of the proposed qualitative system and the ability to estimate lesion severity using both anatomic and clinical factors, we feel that professional societies and clinicians should begin to embrace this simplified means of lesion assessment.

Incidence, Characteristics, Predictors, and Outcomes of Surgical Explantation After Transcatheter Aortic Valve Replacement.

BACKGROUND: Currently, there is a paucity of information on surgical explantation after transcatheter aortic valve replacement (TAVR). OBJECTIVES: The purpose of this study was to examine the incidence, patient characteristics, predictors, and outcomes of surgical explantation after TAVR using a population-based, nationally representative database. METHODS: We analyzed the Medicare Provider profile to include all U.S. patients undergoing TAVR from 2012 to 2017. Time to surgical explant was calculated from the index TAVR discharge to surgical explantation. Post-operative survival was assessed using time-dependent Cox proportional hazard regression analysis and landmark analysis. RESULTS: The incidence of surgical explantation was 0.2% (227 of 132,633 patients), and was 0.28% and 0.14% in the early and newer TAVR era, respectively. The median time to surgical explant was 212 days, whereas 8.8% and 70.9% underwent surgical explantation within 30 days and 1 year, respectively. The primary indication for reintervention was bioprosthetic failure (79.3%). Compared with the no-explant cohort, the explant cohort was significantly younger (mean age 73.7 years vs. 81.7 years), with a lower prevalence of heart failure (55.9% vs. 65.8%) but more likely a lower-risk profile cohort (15% vs. 2.4%; all p < 0.05). The 30-day and 1-year mortality rates were 13.2% and 22.9%, respectively, and did not vary by either time to surgical explant or TAVR era, or between patients with versus without endocarditis (all p > 0.05). The time-dependent Cox regression analysis demonstrated a higher mortality in those with surgical explantation (hazard ratio: 4.03 vs. no-explant group; 95% confidence interval: 1.81 to 8.98). Indication, time-to-surgical-explant, and year of surgical explantation were not associated with worse post-explantation survival (all p > 0.05). CONCLUSIONS: The present study provides updated evidence on the incidence, timing, and outcomes of surgical explantation of a TAVR prosthesis. Although the overall incidence was low, short-term mortality was high. These findings stress the importance of future mechanistic studies on TAVR explantation and may have implications on lifetime management of aortic stenosis, particularly in younger patients.

Quantifying the Impact of Care Fragmentation on Outcomes After Transcatheter Aortic Valve Implantation.

The Center for Medicare & Medicaid Services has identified readmission as an important quality metric in assessing hospital performance and value of care. The aim of this study was to quantify the impact of "care fragmentation" on transcatheter aortic valve implantation (TAVI) outcomes. Readmission to nonindex hospitals was defined as any hospital other than the hospital where the TAVI was performed. In this multicenter, population-based, nationally representative study, a nationally weighted cohort of US adult patients who underwent TAVI in the National Readmission Database between 01/01/2010 and 9/31/2015 were analyzed. Patient characteristics, trends, and outcomes after 90-day nonindex readmission were evaluated. Thirty-day metric was used as a reference group for comparison. A weighted total of 51,092 patients met inclusion criteria. Overall, the 90-day readmission rate after TAVI was 27.6% (30-day reference group: 17.4%), and 42% of these readmissions were to nonindex hospitals. Noncardiac causes accounted for most nonindex readmissions, but major cardiac procedures were more likely performed at index hospitals during readmission within 90 days. Despite the high co-morbidity burden of patients readmitted to nonindex hospitals, unadjusted and risk-adjusted all-cause mortality, readmission length of stay and total hospital costs following nonindex readmission were lower compared with index readmission at 90 days. In conclusion, in this real world, nationally representative cohort of TAVI patients in the United States, care fragmentation remains prevalent and represent an enduring, residual target for future health policies. Although the impactful readmissions may be directed toward index hospitals, concerted efforts are needed to address mechanisms that increase care fragmentation.

Relationship Between Hospital Surgical Aortic Valve Replacement Volume and Transcatheter Aortic Valve Replacement Outcomes.

OBJECTIVES: The aim of this study was to examine whether hospital surgical aortic valve replacement (SAVR) volume was associated with corresponding transcatheter aortic valve replacement (TAVR) outcomes. BACKGROUND: Recent studies have demonstrated a volume-outcome relationship for TAVR. METHODS: In total, 208,400 fee-for-service Medicare beneficiaries were analyzed for all aortic valve replacement procedures from 2012 to 2015. Claims for patients <65 years of age, concomitant coronary artery bypass grafting surgery, other heart valve procedures, or other major open heart procedures were excluded, as were secondary admissions for aortic valve replacement. Hospital SAVR volumes were stratified on the basis of mean annual SAVR procedures during the study period. The primary outcomes were 30-day and 1-year post-operative TAVR survival. Adjusted survival following TAVR was assessed using multivariate Cox regression. RESULTS: A total of 65,757 SAVR and 42,967 TAVR admissions were evaluated. Among TAVR procedures, 21.7% (n = 9,324) were performed at hospitals with <100 (group 1), 35.6% (n = 15,298) at centers with 100 to 199 (group 2), 22.9% (n = 9,828) at centers with 200 to 299 (group 3), and 19.8% (n = 8,517) at hospitals with ≥300 SAVR cases/year (group 4). Compared with group 4, 30-day TAVR mortality risk-adjusted odds ratios were 1.32 (95% confidence interval: 1.18 to 1.47) for group 1, 1.25 (95% confidence interval: 1.12 to 1.39) for group 2, and 1.08 (95% confidence interval: 0.82 to 1.25) for group 3. These adjusted survival differences in TAVR outcomes persisted at 1 year post-procedure. CONCLUSIONS: Total hospital SAVR volume appears to be correlated with TAVR outcomes, with higher 30-day and 1-year mortality observed at low-volume centers. These data support the importance of a viable surgical program within the heart team, and the use of minimum SAVR hospital thresholds may be considered as an additional metric for TAVR performance.