The Impact of Frailty on Outcomes of Proximal Aortic Aneurysm Surgery: A Nationwide Analysis.

(1) Background: This study examines frailty's impact on proximal aortic surgery outcomes. (2) Methods: All patients with a thoracic aortic aneurysm who underwent aortic root, ascending aorta, or arch surgery from the 2016-2017 National Inpatient Sample were included. Frailty was defined by the Adjusted Clinical Groups Frailty Indicator. Outcomes of interest included in-hospital mortality and a composite of death, stroke, acute kidney injury (AKI), and major bleeding (MACE). (3) Results: Among 5745 patients, 405 (7.0%) met frailty criteria. Frail patients were older, with higher rates of chronic pulmonary disease, diabetes, and chronic kidney disease. There was no difference in in-hospital death (4.9% vs. 2.4%, p = 0.169); however, the frail group exhibited higher rates of stroke and AKI. Frail patients had a longer length of stay (17 vs. 8 days), and higher rates of non-home discharge (74.1% vs. 54.3%) than non-frail patients (both p < 0.001). Sensitivity analysis confirmed increased morbidity and mortality in frail individuals. After adjusting for patient comorbidities and hospital characteristics, frailty independently predicted MACE (OR 4.29 [1.88-9.78], p = 0.001), while age alone did not (OR 1.00 [0.99-1.02], p = 0.568). Urban teaching center status predicted a lower risk of MACE (OR 0.27 [0.08-0.94], p = 0.039). (4) Conclusions: Frailty is associated with increased morbidity in proximal aortic surgery and is a more significant predictor of mortality than age. Coordinated treatment in urban institutions may enhance outcomes for this high-risk group.

Procedural success in transaxillary transcatheter aortic valve implantation according to type of transcatheter heart valve: results from the multicenter TAXI registry.

BACKGROUND: Transaxillary (TAx) transcatheter aortic valve implantation (TAVI) is a preferred alternative access in patients ineligible for transfemoral TAVI. AIMS: This study used the Trans-AXillary Intervention (TAXI) registry to compare procedural success according to different types of transcatheter heart valves (THV). METHODS: For the TAXI registry anonymized data of patients treated with TAx-TAVI were collected from 18 centers. Acute procedural, early and 1-month clinical outcomes were adjudicated in accordance with standardized VARC-3 definitions. RESULTS: From 432 patients, 368 patients (85.3%, SE group) received self-expanding (SE) THV and 64 patients (14.8%, BE group) received balloon-expandable (BE) THV. Imaging revealed lower axillary artery diameters in the SE group (max/min diameter in mm: 8.4/6.6 vs 9.4/6.8 mm; p < 0.001/p = 0.04) but a higher proportion of axillary tortuosity in BE group (62/368, 23.6% vs 26/64, 42.6%; p = 0.004) with steeper aorta-left ventricle (LV) inflow (55° vs 51°; p = 0.002) and left ventricular outflow tract (LVOT)-LV inflow angles (40.0° vs 24.5°; 0.002). TAx-TAVI was more often conducted by right sided axillary artery in the BE group (33/368, 9.0% vs 17/64, 26.6%; p < 0.001). Device success was higher in the SE group (317/368, 86.1% vs 44/64, 68.8%, p = 0.0015). In logistic regression analysis, BE THV were a risk factor for vascular complications and axillary stent implantation. CONCLUSIONS: Both, SE and BE THV can be safely used in TAx-TAVI. However, SE THV were more often used and were associated with a higher rate of device success. While SE THV were associated with lower rates of vascular complications, BE THV were more often used in cases with challenging anatomical circumstances.

Race and Socioeconomic Disparities in Proximal Aortic Surgery.

BACKGROUND: Substantial socioeconomics-based disparities exist in cardiac surgery. Although there are robust data for revascularization and valve procedures, the effect of race and socioeconomic status on proximal aortic surgery is not well studied. This study analyzed the impact of race and socioeconomic status on in-hospital outcomes after proximal aortic surgery. METHODS: All adult patients who underwent proximal aortic surgery for aortic dissection or thoracic aneurysm from the 2016 to 2018 National Inpatient Sample were included. Primary outcomes included in-hospital mortality and in-hospital composite morbidity (stroke, pulmonary embolus, major bleeding, acute kidney injury, or permanent pacemaker insertion). Adjusted outcomes were assessed with multivariable analysis. RESULTS: A weighted total of 32,895 patients were included; 25,461 (77.4%) classified as White, 3224 (9.8%) Black, 2039 (6.2%) Hispanic, and 2171 (6.6%) other. Black and Hispanic patients had significantly lower median household income, higher proportion of self-pay insurance status, younger age, higher comorbidity burden, and a higher proportion of urgent or emergency procedures compared with White patients. There was no significant difference in observed in-hospital mortality by patient race, but non-White patients had significantly higher composite morbidity. On adjusted analysis, there was no difference in in-hospital mortality, but non-White race was an independent predictor of in-hospital morbidity (adjusted odds ratio, 1.6; 95% CI, 1.4-1.8; P < .001). CONCLUSIONS: Patients of non-White race who undergo proximal aortic surgery have less insurance coverage, more urgent procedures, and a higher comorbidity burden than White patients, disparities that translate to significantly higher morbidity in non-White. A greater focus on nonfatal outcome differentials and improving access to care likely will improve aortic surgery disparities.

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.

Efficacy of opioid-sparing analgesia after median sternotomy with continuous bilateral parasternal subpectoral plane blocks.

OBJECTIVES: Regional anesthetic techniques, traditionally underutilized in cardiac surgery, may play a role in multimodal analgesia, effectively improving pain control and reducing opioid consumption. We investigated the efficacy of continuous bilateral ultrasound-guided parasternal subpectoral plane blocks following sternotomy. METHODS: We reviewed all opioid-naïve patients who underwent cardiac surgery via median sternotomy under our enhanced recovery after surgery protocol between May 2018 and March 2020. Patients were grouped based on postoperative pain management strategy-those who received standard Enhanced Recovery After Surgery (ERAS) multimodal analgesia alone (no nerve block group) versus those receiving ERAS multimodal analgesia plus continuous bilateral parasternal subpectoral plane blocks (block group). In the block group, parasternal subpectoral plane catheters were placed under ultrasound-guidance on each side of the sternum with initial 0.25% ropivacaine bolus, followed by continuous 0.125% bupivacaine infusions. Postoperative patient-reported numerical rating scale pain scores and opioid consumption in morphine milligram equivalents were compared through postoperative day 4. RESULTS: Of 281 patients included in the study, the block group comprised 125 (44%) patients. Although baseline characteristics, type of surgery, and length of stay were similar between groups, average numerical rating scale pain scores and opioid consumption were significantly lower in the block group through postoperative day 4 (all P values < .05). We also observed a 44% reduction in total opioid consumption after surgery in the block group (75.1 vs 133.1 MME; P = .001) and 1 less hospital day requiring opioids (4.2 vs 3 days; P = .001). CONCLUSIONS: Continuous bilateral parasternal subpectoral plane blocks may further reduce poststernotomy pain and opioid consumption within the context ERAS multimodal analgesia.

Outcomes of Mitral Valve Repair Among High- and Low-Volume Surgeons Within a High-Volume Institution.

BACKGROUND: Volume-outcome relationships have been described for mitral valve repair at the institution and surgeon level. We aimed to assess whether this relationship is mitigated at high-volume (HV) mitral repair centers between HV and low-volume (LV) surgeons. METHODS: All mitral repair cases at an HV mitral center (mean, 192 annual repairs) from 1992 to 2018 were considered. Cases with concomitant procedures other than tricuspid and atrial fibrillation procedures were excluded. Surgeons who performed ≥25 repairs per year were considered HV. The primary outcome was operative mortality; secondary outcomes were operative complications, long-term mortality, and reoperation. RESULTS: In total, 2653 mitral repairs from 19 surgeons were included. The mean age of the patients in the HV and LV groups was 59.6 years and 61.8 years, respectively (P = .005), with no difference in other baseline characteristics. HV surgeons had significantly shorter median aortic cross-clamp times (80 vs 87 minutes; P < .001) compared with LV surgeons; however, there was no significant difference in operative mortality (0.9% vs 1.6%; P = .19), reoperation, perioperative complications, or length of stay. LV surgeons had higher repair conversion to replacement than HV surgeons did (9.0% vs 3.4%; P < .001). In the risk-adjusted analyses, surgeon volume group did not have an impact on longitudinal survival or reoperation. CONCLUSIONS: At an HV mitral repair institution, LV surgeons appear to have short- and long-term outcomes similar to those of HV surgeons despite increased conversion rates. These findings suggest that institutional volume may mitigate the surgeon volume outcome. However, complex repairs may benefit from referral to HV surgeons, given the lower conversion rate.

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.

The Effect of Psychosocial Risk Factors on Outcomes After Aortic Valve Replacement.

BACKGROUND: Psychosocial risk factors (PSRFs) have emerged as important nontraditional risk factors that are associated with worse surgical outcomes but have not been well-characterized in valvular disease. OBJECTIVES: This study evaluates the impact of PSRFs on 30-day outcomes following surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR). METHODS: All adult patients (≥18 years of age) who underwent isolated TAVR or SAVR in the Nationwide Readmissions Database from 2016 to 2018 were included. Patients were classified as having 0 PSRFs vs ≥1 PSRF. PSRFs included limited cognitive understanding, substance use, psychiatric disease, low socioeconomic status, or uninsured status. Primary outcomes included 30-day mortality, readmission, and composite morbidity (stroke, pulmonary embolus, pacemaker implantation, bleeding complications, acute kidney injury, myocardial infarction, or new atrial fibrillation). RESULTS: A nationally weighted total of 74,763 SAVR and 87,142 TAVR patients met inclusion criteria. For SAVR, patients with PSRFs had significantly higher 30-day mortality (4.2% vs 3.7%; P = 0.048) and readmissions (13.1% vs 11.3%; P < 0.001), but there was no difference in composite morbidity. For TAVR, patients with PSRFs had significantly higher 30-day readmission (11.7% vs 10.7%; P = 0.012) but no difference in 30-day mortality or composite morbidity. On risk-adjusted analysis, presence of PSRFs was a significant predictor of higher 30-day readmissions following SAVR (adjusted OR: 1.10; 95% CI: 1.02-1.19). CONCLUSIONS: The presence of PSRFs is associated with worse short-term outcomes following SAVR and TAVR, with a more profound impact in SAVR. This study highlights the importance of identifying at-risk patients and suggests that TAVR may be beneficial in patients with less social support.

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.

Early outcomes following transatrial transcatheter mitral valve replacement in patients with severe mitral annular calcification.

OBJECTIVE: Implantation of a transcatheter valve-in-mitral annular calcification (ViMAC) has emerged as an alternative to traditional surgical mitral valve (MV) replacement. Previous studies evaluating ViMAC aggregated transseptal, transapical, and transatrial forms of the procedure, leaving uncertainty about each technique's advantages and disadvantages. Thus, we sought to evaluate clinical outcomes specifically for transatrial ViMAC from the largest multicenter registry to-date. METHODS: Patients with symptomatic MV dysfunction and severe MAC who underwent ViMAC were enrolled from 12 centers across the United States and Europe. Clinical characteristics, procedural details, and clinical outcomes were abstracted from the electronic record. The primary end point was all-cause mortality. RESULTS: We analyzed 126 patients who underwent ViMAC (median age 76 years [interquartile range {IQR}, 70-82 years], 28.6% female, median Society of Thoracic Surgeons score 6.8% [IQR, 4.0-11.4], and median follow-up 89 days [IQR, 16-383.5]). Sixty-one (48.4%) had isolated mitral stenosis, 25 (19.8%) had isolated mitral regurgitation (MR), and 40 (31.7%) had mixed MV disease. Technical success was achieved in 119 (94.4%) patients. Thirty (23.8%) patients underwent concurrent septal myectomy, and 8 (6.3%) patients experienced left ventricular outflow tract obstruction (7/8 did not undergo myectomy). Five (4.2%) patients of 118 with postprocedure echocardiograms had greater than mild paravalvular leak. Thirty-day and 1-year all-cause mortality occurred in 16 and 33 patients, respectively. In multivariable models, moderate or greater MR at baseline was associated with increased risk of 1-year mortality (hazard ratio, 2.31; 95% confidence interval, 1.07-4.99, P = .03). CONCLUSIONS: Transatrial ViMAC is safe and feasible in this selected, male-predominant cohort. Patients with significant MR may derive less benefit from ViMAC than patients with mitral stenosis only.

Aortic root management in acute type A aortic dissection: A nationwide analysis.

OBJECTIVE: Acute type A aortic dissection (ATAAD) is a life-threatening condition and surgical repair often includes aortic valve replacement (AVR). Aortic valve repair (AVr) is increasingly being reported with favorable outcomes from single-center experiences. This study examined national trends and outcomes of AVr in patients with ATAAD. METHODS: Adults with a primary diagnosis of acute thoracic aortic dissection who underwent proximal aortic surgery from January 2016 to December 2017 were obtained from the National Inpatient Sample. Patients were stratified into an isolated aortic surgery group (no aortic valve procedure), concomitant AVR, or concomitant AVr groups. The primary outcome was in-hospital mortality and secondary outcomes included stroke, acute kidney injury, heart block, and bleeding. Propensity score matching was used to address patient and hospital-level confounders between AVR and AVr groups. RESULTS: In total, 5115 patients underwent surgery for ATAAD and were included. Overall, 3220 (63%) underwent isolated ATAAD repair, while 1120 (22%) had concomitant AVR, and 775 (15%) had concomitant AVr. In 455 propensity-matched pairs, there was no difference in mortality or stroke between AVr and AVR groups, however, heart block (1.1% vs. 7.5%, p < .001) and bleeding (65.9% vs. 81.3%, p < .001) were significantly less common among those who underwent AVr. Patients who underwent AVr had shortest LOS (11.9 vs. 13.5 days, p < .001). There were no differences in outcomes of AVr in ATAAD based on hospital size or teaching status. CONCLUSION: In selected patients, AVr is being performed safely in the setting of ATAAD with mortality and composite outcomes comparable to AVR.

Risk stratification of new persistent left bundle branch block after transcatheter aortic valve implantation

ABSTRACT Previous studies reported that new-onset persistent left bundle branch block (NOP-LBBB) was related to worse outcomes after transcatheter aortic valve implantation (TAVI). However, these results can be confounded by the presence of permanent pacemaker (PPM) implantation before and after TAVI. Long-term outcomes and the risk stratification of NOP-LBBB not having PPM implantation before and after TAVI have not been fully investigated. This is an international, multicenter, retrospective study of patients who underwent TAVI from July 31, 2007, to May 8, 2020. A total of 2,240 patients were included, and 17.5% of patients developed NOP-LBBB. NOP-LBBB was associated with cardiac mortality (adjusted hazard ratio [aHR] 1.419, 95% confidence interval [CI] 1.014 to 1.985, p = 0.041) and the composite outcomes of cardiac mortality and/or heart failure readmission (aHR 1.313, 95% CI 1.027 to 1.678, p = 0.030). Patients who developed NOP-LBBB with pre-TAVI left ventricular ejection fraction (LVEF) <40% were significantly associated with cardiac mortality (aHR 2.049, 95% CI 1.039 to 4.041, p = 0.038), heart failure (aHR 3.990, 95% CI 2.362 to 6.741, p <0.001), and the composite outcome (aHR 2.729, 95% CI 1.703 to 4.374, p <0.001). Although NOP-LBBB with pre-TAVI LVEF >40% had a significant decrease in LVEF 6 to 12 months after TAVI (-1.8 ± 9.7% vs +0.6 ± 8.1%, p = 0.003), NOP-LBBB with pre-TAVI LVEF <40% had a significant increase in LVEF 6 to 12 months after TAVI (+9.7 ± 13.6% vs +13.0 ± 11.7%, p = 0.157). In conclusion, patients with NOP-LBBB without pre-TAVI and post-TAVI PPM developed significantly worse long-term outcomes, especially in patients with pre-TAVI LVEF <40%. Further prospective investigation should be undertaken.

Contemporary socioeconomic-based disparities in cardiac surgery: Are we closing the disparities gap?

OBJECTIVE: Female sex and lower income residence location are associated with worse health care outcomes. In this study we analyzed the national, contemporary status of socioeconomic disparities in cardiac surgery. METHODS: Adult patients within the Nationwide Readmissions Database who underwent coronary artery bypass grafting (CABG), surgical aortic valve replacement (SAVR), mitral valve (MV) replacement, MV repair, or ascending aorta surgery from 2016 to 2018 were included. Sex and median household income quartile (MHIQ) were compared within each surgery group. Primary outcome was 30-day mortality. Multivariable analysis was adjusted for patient characteristics and hospital-level factors. RESULTS: A weighted total of 358,762 patients were included. Fewer women underwent CABG (22.3%), SAVR (32.2%), MV repair (37.5%), and ascending aorta surgery (29.7%). In adjusted analysis, female sex was independently associated with higher 30-day mortality rates after CABG (adjusted odds ratio [aOR], 1.6), SAVR (aOR, 1.4), MV repair (aOR, 1.8), and ascending aorta surgery (aOR, 1.2; all P < .03). The lowest MHIQ was independently associated with higher 30-day mortality rates after CABG (aOR, 1.4), SAVR (aOR, 1.5), MV replacement (aOR, 1.3), and ascending aorta surgery (aOR, 1.8; all P < .004) compared with the highest quartile. Women were less likely to receive care at urban and academic hospitals for CABG compared with men. Patients of lower MHIQ received less care at urban and academic institutions for all surgeries. CONCLUSIONS: Despite advances in the techniques and safety, women and patients of lower socioeconomic status continue to have worse outcomes after cardiac surgery. These persistent disparities warrant the need for root cause analysis.

Risk Stratification of New Persistent Left Bundle Branch Block After Transcatheter Aortic Valve Implantation.

Previous studies reported that new-onset persistent left bundle branch block (NOP-LBBB) was related to worse outcomes after transcatheter aortic valve implantation (TAVI). However, these results can be confounded by the presence of permanent pacemaker (PPM) implantation before and after TAVI. Long-term outcomes and the risk stratification of NOP-LBBB not having PPM implantation before and after TAVI have not been fully investigated. This is an international, multicenter, retrospective study of patients who underwent TAVI from July 31, 2007, to May 8, 2020. A total of 2,240 patients were included, and 17.5% of patients developed NOP-LBBB. NOP-LBBB was associated with cardiac mortality (adjusted hazard ratio [aHR] 1.419, 95% confidence interval [CI] 1.014 to 1.985, p = 0.041) and the composite outcomes of cardiac mortality and/or heart failure readmission (aHR 1.313, 95% CI 1.027 to 1.678, p = 0.030). Patients who developed NOP-LBBB with pre-TAVI left ventricular ejection fraction (LVEF) <40% were significantly associated with cardiac mortality (aHR 2.049, 95% CI 1.039 to 4.041, p = 0.038), heart failure (aHR 3.990, 95% CI 2.362 to 6.741, p <0.001), and the composite outcome (aHR 2.729, 95% CI 1.703 to 4.374, p <0.001). Although NOP-LBBB with pre-TAVI LVEF >40% had a significant decrease in LVEF 6 to 12 months after TAVI (-1.8 ± 9.7% vs +0.6 ± 8.1%, p = 0.003), NOP-LBBB with pre-TAVI LVEF <40% had a significant increase in LVEF 6 to 12 months after TAVI (+9.7 ± 13.6% vs +13.0 ± 11.7%, p = 0.157). In conclusion, patients with NOP-LBBB without pre-TAVI and post-TAVI PPM developed significantly worse long-term outcomes, especially in patients with pre-TAVI LVEF <40%. Further prospective investigation should be undertaken.

Percutaneous vs. surgical axillary access for transcatheter aortic valve implantation: the TAXI registry.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is an established management strategy for severe aortic valve stenosis. Percutaneous axillary approach for TAVI holds the promise of improving safety without jeopardizing effectiveness in comparison to surgical access. We aimed at appraising the comparative effectiveness of percutaneous vs. surgical axillary approaches for TAVI. METHODS: We performed an international retrospective observational study using de-identified details on baseline, procedural, and 1-month follow-up features. Valve Academic Research Consortium (VARC)-3 criteria were applied throughout. Outcomes of interest were clinical events up to 1 month of follow-up, compared with unadjusted and propensity score-adjusted analyses. RESULTS: A total of 432 patients were included, 189 (43.8%) receiving surgical access, and 243 (56.2%) undergoing percutaneous access. Primary hemostasis failure was more common in the percutaneous group (13.2% vs. 4.2%, P<0.001), leading to more common use of covered stent implantation (13.2% vs. 3.7%, P<0.001). Irrespectively, percutaneous access was associated with shorter hospital stay (-2.6 days [95% confidence interval: -5.0; -0.1], P=0.038), a lower risk of major adverse events (a composite of death, myocardial infarction, stroke, type 3 bleeding, and major access-site related complication; odds ratio=0.44 [0.21; 0.95], P=0.036), major access-site non-vascular complications (odds ratio=0.21 [0.06; 0.77], P=0.018), and brachial plexus impairment (odds ratio=0.16 [0.03; 0.76], P=0.021), and shorter hospital stay (-2.6 days [-5.0; -0.1], P=0.038). CONCLUSIONS: Percutaneous axillary access provides similar or better results than surgical access in patients undergoing TAVI with absolute or relative contraindications to femoral access.

Marital Status and Sex-Based Differences in Outcomes After Transcatheter Aortic Valve Implantation.

Studies have shown improved outcomes among married patients who underwent cardiovascular surgery; however, this has not been well studied in transcatheter aortic valve implantation (TAVi). We examined the impact of marital status and patient sex on outcomes after TAVi. Patients who underwent TAVi from January 2015 to June 2018 were reviewed and stratified into 3 groups: single, married, and widowed. The impact of marital status and sex on 30-day outcomes was assessed using a stepwise logistic regression analysis. Cumulative survival was estimated using Kaplan-Meier analysis and adjusted survival with multivariable Cox proportional hazards modeling. A total of 785 patients were included: 149 single, 413 married, and 223 widowed. Widowed patients were older (84 vs 79 years) with higher Society of Thoracic Surgeons risk scores (6.79% vs 5.51%, both p ≤0.001) than married patients. Neither marital status nor sex was associated with 30-day mortality or home discharge. However, 1-year survival revealed a differential survival penalty, with married females (p = 0.041) having lower survival and married males (p = 0.007) having higher survival than their single counterparts. This survival penalty persisted in the adjusted analyses (married females hazard ratio [HR] 2.24, p = 0.009; widowed males HR 2.42, p = 0.057). For patients who were readmitted in the first year, adjusted analysis showed widowed status was associated with higher 30-day readmissions (HR 1.91, p = 0.012) in both sexes. In conclusion, these findings suggest that marital status does not impact both sexes equally after TAVi; identifying at-risk patients and targeted interventions, such as adjusting discharge planning to ensure adequate home social support, may help improve outcomes.

Debunking the July Effect in Transcatheter Interventions in Structural Heart Disease: Truth or Myth?

Background: The "July effect", the perception of worse outcomes in the first month of training, has been previously demonstrated in critical care medicine and general surgery. However, the July effect in the context of structural heart interventions (i.e., transcatheter aortic valve replacement [TAVR] and MitraClip) remains unknown. Methods: All adult patients undergoing TAVR or MitraClip in the 2012-2016 National Inpatient Sample were included. Outcomes were compared by procedure month and academic year quartiles (i.e., between the first academic year quartile [Q1] vs. the fourth quartile [Q4]). Outcomes between teaching and nonteaching hospitals were compared using risk-adjusted logistic difference-in-difference regression. Results: During the study period, 94,170 TAVR (Q1: 25,250; Q4: 23,170) and 8750 MitraClip (Q1: 2220; Q4: 2150) procedures were performed. In-hospital mortality did not vary as per academic year quartiles for either procedure, even after risk adjustment. These findings persisted in sensitivity analysis by procedure month and newer device era (2015-2016; all p > 0.05). In the subgroup analysis, the unadjusted and adjusted Q1 vs. Q4 in-hospital mortality between teaching and nonteaching hospitals were similar for either procedure. In-hospital mortality also did not vary by procedure month when stratified by hospital teaching status for both procedures. However, postprocedural complication rates appeared to be improving among the TAVR teaching hospitals for stroke, major bleeding, and vascular complications (all p < 0.05). Conclusions: In this large, nationwide study, the July effect was not evident for structural heart interventions. With increasing interest and growth in transcatheter procedures, early resident and fellow teaching can be achieved with appropriate supervision.