Infarct exclusion repair of postmyocardial infarction ventricular septal rupture with a hybrid patch and septal occluder device compared with patch only.

Objective: We developed a hybrid technique for repairing post-myocardial infarction (MI) ventricular septal defect (VSD) that combines infarct exclusion with patch and a nitinol-mesh septal occluder device (SOD) to provide a scaffold to support the damaged septal wall. Here, we compare outcomes of patients with post-MI VSD repaired using patch only or hybrid patch/SOD. Methods: Patients undergoing post-MI VSD repair at our institution from 2013 to 2022 who received patch alone or patch/SOD repair were analyzed. Primary outcome was survival to hospital discharge. Clinical outcomes and echocardiograms were also analyzed. Results: Over a 9-year period, 24 patients had post-MI VSD repair at our institution with either hybrid patch/SOD (n = 10) or patch only repair (n = 14). VSD size was 18 ± 5.8 mm for patch/SOD and 17 ± 4.6 mm for patch only. In the patch/SOD repair cohort, average size of SOD implant was 23.6 ± 5.6 mm. Mild left ventricular dysfunction was present prerepair and was unchanged postrepair in both groups; however, moderate-to-severe right ventricular (RV) dysfunction was common in both groups before repair. RV function worsened or persisted as severe in 10% of hybrid versus 54% of patch-only patients postrepair. Tricuspid annular systolic excursion and RV:left ventricle diameter ratio, quantitative metrics of RV function, improved after patch/SOD repair. No intraoperative mortality occurred in either group. Postoperative renal, hepatic, and respiratory failure requiring tracheostomy was common in both groups. Survival to hospital discharge in both cohorts was 70%. Conclusions: Post-MI VSD repair with patch/SOD has comparable short-term outcomes with patch alone. Addition of a SOD to patch repair provides a scaffold that may enhance the repair of post-MI VSD with patch exclusion.

Improving patient outcomes with a mobile digital health platform for patients undergoing transcatheter aortic valve replacement.

PURPOSE: ManageMySurgery (MMS) is a digital health application (app) for patients undergoing surgery, including Transcatheter Aortic Valve Replacement (TAVR). Patients using MMS review procedure-specific education, view FAQs, and report patient-reported outcomes. This study assessed the impact of app use on postoperative outcomes. METHODS: Patients who underwent TAVR and invited to use MMS between March 2019 and November 2021 were identified. Patients received standard perioperative care and were defined as App users if they signed into the app at least once and engaged with at least one task or FAQ. Demographics and postoperative outcomes were collected via medical record review. Multivariable logistic regression models were used to determine odds of 90-day readmission, Emergency Room (ER) visits, and complications. RESULTS: 388 patients met inclusion criteria, of which 238 used the app. The average age at surgery was 76.4±7.7 years for users and 78.1±7.6 for non-users. 63.0% of users and 59.3% of non-users were male. App users had significantly lower 90-day readmission rates, (8.8% vs 16.0%, OR=0.51, p=0.0373), ER visit rates (12.6% vs 27.3%, OR=0.36, p=0.0003), and complication rates (Minor: 12.2% vs 20.7%, OR=0.48, P=0.0126; Major: 8.8% vs. 16%, OR=0.47, P=0.0235). CONCLUSIONS: In this non-randomized, retrospective study, we found significant decreases in 90-day readmissions, ER visits, and complications in TAVR patients using an app compared to traditional care. By engaging patients throughout their interventional journey with structured education and tasks, mobile health platforms may mitigate unnecessary use of emergency and inpatient care, thereby improving patient well-being and lowering the burden on healthcare resources.

Surgical Sutureless and Sutured Aortic Valve Replacement in Low-risk Patients.

BACKGROUND: Randomized clinical trials have shown that transcatheter aortic valve replacement is noninferior to surgery in low surgical risk patients. We compared outcomes in patients treated with a sutured (stented or stentless) or sutureless surgical valve from the Evolut Low Risk Trial. METHODS: The Evolut Low Risk Trial enrolled patients with severe aortic stenosis and low surgical risk. Patients were randomized to self-expanding transcatheter aortic valve replacement or surgery. Use of sutureless or sutured valves was at the surgeons' discretion. RESULTS: Six hundred eighty patients underwent surgical aortic valve implantation (205 sutureless, 475 sutured). The Valve Academic Research Consortium-2 30-day safety composite endpoint was similar in the sutureless and sutured group (10.8% vs 11.0%, P = .93). All-cause mortality between groups was similar at 30 days (0.5% vs 1.5%, P = .28) and 1 year (3.3% vs 2.6%, P = .74). Disabling stroke was also similar at 30 days (2.0% vs 1.5%, P = .65) and 1 year (2.6% vs 2.2%, P = .76). Permanent pacemaker implantation at 30 days was significantly higher in the sutureless compared with the sutured group (14.4% vs 2.9%, P < .001). Aortic valve-related hospitalizations occurred more often at 1 year with sutureless valves (9.1% vs 5.1%, P = .04). Mean gradients 1 year after sutureless and sutured aortic valve replacement were 9.9 ± 4.2 versus 11.7 ± 4.7 mm Hg (P < .001). CONCLUSIONS: Among low-risk patients, sutureless versus sutured valve use did not demonstrate a benefit in terms of 30-day complications and produced marginally better hemodynamics but with an increased rate of pacemaker implantation and valve-related hospitalizations.

Five-Year Clinical and Quality of Life Outcomes From the CoreValve US Pivotal Extreme Risk Trial.

BACKGROUND: Older adults with comorbidities who are at extreme risk for surgical aortic valve replacement may be appropriate candidates for transcatheter aortic valve replacement (TAVR). We present the 5-year clinical, echocardiographic, and health status outcomes of such patients treated with CoreValve self-expanding supra-annular TAVR. METHODS: The CoreValve US Extreme Risk Pivotal Trial was a prospective, nonrandomized, single-arm clinical trial of TAVR at 41 sites in the United States. The primary outcome was all-cause mortality or major stroke. Secondary outcomes included echocardiographic parameters and patient-reported health status, assessed with the Kansas City Cardiomyopathy Questionnaire. RESULTS: Between February 2011 and August 2012, 639 patients with severe aortic stenosis at extreme surgical risk underwent attempted TAVR (mean age 82.8±8.4 years, 53% women, mean Society of Thoracic Surgeons Predicted Risk of Mortality 10.4±5.6%, 77% iliofemoral access). The 5-year Kaplan-Meier rate of death or major stroke was 72.6% ([95% CI, 68.4%­76.7%]; death 71.6%, major stroke 11.5%), with no significant differences according to access site. Among patients who survived 5 years, mean transvalvular gradient was 7.5±5.9 mm Hg, and 3.1% had moderate or severe aortic regurgitation. Health status measures improved significantly by 1 month after TAVR through 1 year (mean change in Kansas City Cardiomyopathy Questionnaire­Overall Summary score 24.8 points [95% CI, 22.4­27.2]). Beyond 1 year, the Kansas City Cardiomyopathy Questionnaire­Overall Summary score decreased gradually but remained significantly improved from pre-TAVR through 5 years of follow-up among surviving patients (mean change from baseline, 14.3 points [95% CI, 10.7­17.9]). CONCLUSIONS: Patients with severe aortic stenosis at extreme surgical risk who are treated with self-expanding supra-annular TAVR have high 5-year mortality. However, the short-term benefits of TAVR in terms of valve hemodynamics and quality of life are mostly preserved among surviving patients at 5 years, thereby supporting the continued use of TAVR in these challenging patients. REGISTRATION: https://www.clinicaltrials.gov; Unique identifier: NCT01240902.

Variation in Antithrombotic Therapy and Clinical Outcomes in Patients With Preexisting Atrial Fibrillation Undergoing Transcatheter Aortic Valve Replacement: Insights From the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry.

BACKGROUND: Optimal antithrombotic management of patients with preexisting atrial fibrillation undergoing transcatheter aortic valve replacement is challenging given the need to balance the risk of bleeding and thromboembolism. We aimed to examine variation in care and association of antithrombotic therapies with 1-year outcomes of stroke, bleeding, and mortality in patients undergoing transcatheter aortic valve replacement with concomitant atrial fibrillation in the United States. METHODS: Patients who underwent transcatheter aortic valve replacement with preexisting atrial fibrillation from November 2011 through September 2015 in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy registry linked to the Medicare database were examined according to receipt of oral anticoagulants (OACs) or antiplatelet therapies (APTs) or a combination of these (OAC+APT) at discharge. To assess the associations of antithrombotic therapies with 1-year outcomes of stroke, bleeding, and mortality, we utilized inverse probability weighting for antithrombotic therapies and multivariable regression modeling to adjust for patient- and hospital-level variables. RESULTS: In the 11 382 patients included in our study, 5833 (51.2%) were discharged on OAC+APT, 4786 (42.0%) on APT alone, and 763 (6.7%) on OAC alone. There was significant variability in discharge medication patterns, including 42% of patients discharged without OAC therapy. In adjusted analyses, the risk for all-cause mortality and stroke was not significantly different when comparing the 3 different antithrombotic strategies. Risk of bleeding was higher with OAC+APT compared with APT alone (hazard ratio, 1.16 [95% CI, 1.05­1.27]) and similar compared with OAC alone (hazard ratio, 1.17 [95% CI, 0.93­1.47]). CONCLUSIONS: There was significant variability in discharge medication patterns across US sites in patients with atrial fibrillation undergoing transcatheter aortic valve replacement, including significant underuse of OAC in this high-risk cohort. The use of OAC+APT (versus OAC alone or APT alone) was not associated with a lower risk of stroke or mortality but was associated with increased risk of bleeding complications at 1 year compared with APT alone.

Geographic Access to Transcatheter Aortic Valve Replacement Centers in the United States: Insights From the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry.

Importance: Geographic access to transcatheter aortic replacement (TAVR) centers varies in the United States as a result of controlled expansion through minimum volume requirements. Objective: To describe the current geographic access to TAVR centers in the United States. Design, Setting, and Participants: Observational study from June 1, 2015, to June 30, 2017. United States census data were used to describe access to TAVR center. Google Maps and the Society of Thoracic Surgeons American College of Cardiology Transcatheter Valve Therapy Registry were used to describe characteristics of patients undergoing successful TAVR according to proximity to implanting center. The study analyzed 47 527 537 individuals 65 years and older in the United States and 31 098 patients who underwent successful transfemoral TAVR, were linked to fee-for-service Medicare, and had a measurable driving time. Main Outcomes and Measures: Median driving distance to a TAVR center. Results: Among 40 537 zip codes in the United States, 490 (1.2%) contained a TAVR center, and among 305 hospital referral regions (HRR), 234 (76.7%) contained a TAVR center. Of the 31 749 patients who underwent successful transfemoral TAVR and were linked to fee-for-service Medicare, 31 098 had a measurable driving time. Mean (SD) age was 82.4 (6.9) years, 14 697 patients (47.3%) were women, and 7422 (23.87%) lived in a rural area. This translated to 1 232 568 of 47 527 537 individuals (2.6%) 65 years and older living in a zip code with a TAVR center and 43 789 169 (92.1%) living in an HRR with a TAVR center. Among 31 749 patients who underwent successful transfemoral TAVR and were linked to fee-for-service Medicare, 31 098 had a measurable driving time. All of these patients (100.0%) underwent their procedure in a TAVR center within their HRR, with 1350 (4.3%) undergoing TAVR in a center within their home zip code. Median driving time to implanting TAVR center was 35.0 minutes (IQR, 20.0-70.0 minutes), ranging from 2.0 minutes to 18 hours and 48 minutes. Conclusions and Relevance: Most US individuals 65 years and older live in an HRR with a TAVR center. Among patients undergoing successful transfemoral TAVR, median driving time to implanting center was 35.0 minutes. Within the context of the US health care system, where certain advanced procedures and specialized care are centralized, TAVR services have significant penetration. More studies are required to evaluate the effect of geographic location of TAVR sites on access to TAVR procedures among individuals with an indication for a TAVR within the US population.

Transcatheter aortic valve replacement for patients with severe bicuspid aortic stenosis.

BACKGROUND: Patients with bicuspid aortic valve stenosis (BAV) were excluded from all the trileaflet aortic valve stenosis (TAV) pivotal trials, and therefore, their outcomes are not clearly defined. The aim of the study was to evaluate the outcomes of transcatheter aortic valve replacement (TAVR) in patients with BAV and compared them with those of TAV. METHODS: We evaluated the outcomes following TAVR of patients with BAV at our institution between April 2011 and November 2016 and compared them with the outcomes of patients with TAV treated with TAVR. The χ2 and the Mann-Whitney U tests were used to compare the groups, and a Kaplan-Meier analysis was performed to estimate long-term survival. RESULTS: TAVR was performed in a total of 567 patients, from which 50 (8.8%) had BAV and 517 (91.2%) had TAV. Patients with BAV were younger and had higher prevalence of chronic obstructive pulmonary disease, lower prevalence of coronary artery disease, higher body mass index, and lower Society of Thoracic Surgeons score (STS PROM). Patients with BAV had a slightly higher mean aortic valve gradient postoperatively (median 12 mm Hg [10-15] vs 10 [7-13], P < .001), but paravalvular aortic regurgitation was not different between the groups (> mild 4.0% vs 3.5%, P = .541). Clinical outcomes were not different between the groups, including stroke (2.0% vs 1.5, P = .567) and the 30-day all-cause mortality (6.0% vs 1.5, P = .064). The 2-year survival (82.0% vs 83.4, P = .476) was similar between the groups. CONCLUSIONS: This initial experience suggests that TAVR can be safely performed in patients with BAV, achieving similar short-term procedural and clinical outcomes when compared with patients with TAV.

Outcomes of Transcatheter Aortic Valve Replacement in Patients With Bicuspid Aortic Valve Disease: A Report From the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry.

BACKGROUND: Patients with bicuspid aortic valve (AV) stenosis were excluded from the pivotal evaluations of transcatheter AV replacement (TAVR) devices. We sought to evaluate the outcomes of TAVR in patients with bicuspid AV stenosis in comparison with those with tricuspid AV stenosis. METHODS: We used data from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry (November 2011 through November 2018) to determine device success, procedural outcomes, post-TAVR valve performance, and in-hospital clinical outcomes (mortality, stroke, and major bleeding) according to valve morphology (bicuspid versus tricuspid). Results were stratified by older and current (Sapien 3 and Evolut R) generation valve prostheses. Medicare administrative claims were used to evaluate mortality and stroke to 1 year among eligible individuals (≥65 years). RESULTS: After exclusions, there were 170 959 eligible procedures at 593 sites during the specified interval. Of these, 5412 TAVR procedures (3.2%) were performed in patients with bicuspid AV, including 3705 with current-generation devices. In comparison with patients with tricuspid valves, patients with bicuspid AV were younger and had a lower Society of Thoracic Surgeons Predicted Risk of Operative Mortality score. When current-generation devices were used to treat patients with bicuspid AV, device success increased (93.5 versus 96.3; P=0.001) and the incidence of 2+ aortic insufficiency declined (14.0% versus 2.7%; P<0.001) in comparison with older-generation devices. With current-generation devices, device success was slightly lower in the bicuspid (versus tricuspid) AV group (96.3% in bicuspid versus 97.4% in tricuspid, P=0.07), with a slightly higher incidence of residual moderate or severe aortic insufficiency among patients with bicuspid AV (2.7% versus 2.1%; P<0.001). A lower 1-year adjusted risk of mortality (hazard ratio, 0.88 [95% CI, 0.78-0.99]) was observed for patients with bicuspid AV versus patients with tricuspid AV in the Medicare-linked cohort, whereas no difference was observed in the 1-year adjusted risk of stroke (hazard ratio, 1.14 [95% CI, 0.94-1.39]). CONCLUSIONS: Using current-generation devices, procedural, postprocedural, and 1-year outcomes were comparable following TAVR for bicuspid AV versus tricuspid AV disease. With newer-generation devices, TAVR is a viable treatment option for patients with bicuspid AV disease.

Incidence, Temporal Trends, and Associated Outcomes of Vascular and Bleeding Complications in Patients Undergoing Transfemoral Transcatheter Aortic Valve Replacement: Insights From the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapies Registry.

BACKGROUND: Vascular and bleeding complications were commonly reported in transcatheter aortic valve replacement clinical trials. Little is known about complication rates in contemporary US clinical practice or clinical outcomes associated with these complications. METHODS: In the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry, we evaluated patients undergoing transcatheter aortic valve replacement from November 1, 2011 to June 30, 2016. The primary outcomes were in-hospital vascular complications and bleeding events. Secondary outcomes included all-cause mortality, stroke, and rehospitalization at 1 year. P values for trends were calculated for rates over time, and multivariable logistic regression was used to determine the association between vascular/bleeding complications and in-hospital clinical outcomes. RESULTS: Overall, 34 893 patients undergoing transcatheter aortic valve replacement at 445 hospitals were analyzed. Of these, 9.3% (n=3257) experienced a vascular complication while 7.6% (n=2651) had an in-hospital bleeding event. Rates of both vascular complications and bleeding events decreased over time (P value for trend test <0.0001); however, there was significant variation in rates across hospital sites (adjusted median rate, 11.4%; IQR, 8.9-14.5). Vascular complications were independently associated with 30-day death (adjusted HR, 2.23 [95% CI, 1.80-2.77]) and death (adjusted HR, 1.17 [95% CI, 1.05-1.30]) and rehospitalization (adjusted HR, 1.14 [95% CI, 1.07-1.22]) at 1 year. Bleeding events were also associated with 30-day death (adjusted HR, 3.71 [95% CI, 2.94-4.69]), and with death (adjusted HR, 1.39 [95% CI, 1.23-1.56]) and hospital readmission (adjusted HR, 1.19 [95% CI, 1.11-1.27]) at 1 year. CONCLUSIONS: In patients undergoing transcatheter aortic valve replacement in the US, vascular complications and in-hospital bleeding events were common, but rates have declined over time with significant variation in complication rates across hospital sites. Vascular and bleeding complications are both associated with worse short- and long-term clinical outcomes including all-cause mortality. Further innovation to reduce sheath sizes and optimize antithrombotic therapy is necessary to reduce the incidence of these detrimental complications.

Incidence and Outcomes of Surgical Bailout During TAVR: Insights From the STS/ACC TVT Registry.

OBJECTIVES: The aim of this study was to evaluate the incidence and outcomes of surgical bailout during transcatheter aortic valve replacement (TAVR). BACKGROUND: The incidence and outcomes of unplanned conversion to open heart surgery, or "surgical bailout," during TAVR are not well characterized. METHODS: Data from the Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry was analyzed with respect to whether surgical bailout was performed during the index TAVR procedure. A Cox proportional hazards models was used to evaluate 1-year mortality and major adverse cardiovascular events. RESULTS: Between November 2011 and September 2015, a total of 47,546 patients underwent TAVR. Surgical bailout during TAVR was performed in 1.17% of the cases (n = 558); the most frequent indications were valve dislodgement (22%), ventricular rupture (19.9%), and aortic valve annular rupture (14.2%). The incidence of surgical bailout significantly decreased over time (first tertile 1.25%, second tertile 1.43%, third tertile 1.04%; p = 0.0088). The 30-day and 1-year incidence of major adverse cardiovascular events (54.6% vs. 7.4% [p < 0.0001] and 63.92% vs. 20.29% [p < 0.0001]) and all-cause mortality (50.00% vs. 4.98% [p < 0.0001] and 59.79% vs. 17.06% [p < 0.0001]) were significantly higher in those who underwent bailout. Independent predictors of surgical bailout included female sex, hemoglobin, left ventricular ejection fraction, nonelective cases, and nonfemoral access. Body surface area was the only independent predictor of survival after surgical bailout. CONCLUSIONS: In a large, nationally representative registry, the need for surgical bailout in patients undergoing TAVR is low, and its incidence has decreased over time. However, surgical bailout after TAVR is associated with poor outcomes, including 50% mortality at 30 days.

Factors Associated With and Outcomes of Aborted Procedures During Elective Transcatheter Aortic Valve Replacement.

OBJECTIVES: This study sought to evaluate the outcomes and factors associated with aborted procedures among patients undergoing elective transcatheter aortic valve replacement (TAVR). BACKGROUND: Elective TAVR procedures can be aborted because of device limitations or aborted for other reasons, including patient and procedural factors. Little is known about 30-day outcomes and factors associated with aborted procedures and procedures aborted because of device limitations (ADs). METHODS: Patients undergoing elective TAVR procedures from 2011 to 2017 in the Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry were examined. The incidence of aborted procedures, both ADs and procedures aborted for other reasons (AOs), was examined. Rates of 30-day all-cause death or stroke and a composite of vascular complications and bleeding events were compared between patients with and those without aborted procedures and between patients with ADs and those with AOs. Multivariate modeling identified factors associated with aborted procedures and ADs. RESULTS: Among 106,169 patients who underwent TAVR between 2011 and 2017, procedures were aborted in 1,150 (1.1%) (581 ADs and 569 AOs). Patients with aborted procedures were more likely female with peripheral artery disease and more often treated at lower volume centers compared with those with nonaborted procedures (p < 0.01 for all). The incidence of aborted procedures and ADs decreased over the study period (p < 0.01). The adjusted rates of 30-day death and stroke were greater for aborted versus nonaborted procedures (odds ratio: 5.02; 95% confidence interval: 4.13 to 6.11). Peripheral artery disease, alternative access, and low institutional TAVR volume were factors associated with aborted procedures and ADs (p < 0.05 for all). CONCLUSIONS: The incidence of aborted procedures is declining, but peripheral artery disease and low institutional TAVR volume remain associated with aborted procedures. A thorough pre-procedural assessment and referral of challenging cases to high-volume centers may be strategies to minimize aborted procedures.

Relation of Postdischarge Care Fragmentation and Outcomes in Transcatheter Aortic Valve Implantation from the STS/ACC TVT Registry.

Fragmented care following elective surgery has been associated with poor outcomes. The association between fragmented care and outcomes in patients undergoing transcatheter aortic valve implantation (TAVI) is unknown. We examined patients who underwent TAVI from 2011 to 2015 at 374 sites in the STS/ACC TVT Registry, linked to Center for Medicare and Medicaid Services claims data. Fragmented care was defined as at least one readmission to a site other than the implanting TAVI center within 90 days after discharge, whereas continuous care was defined as readmission to the same implanting center. We compared adjusted 1-year outcomes, including stroke, bleeding, heart failure, mortality, and all-cause readmission in patients who received fragmented versus continuous care. Among 8,927 patients who received a TAVI between 2011 and 2015, 27.4% were readmitted within 90 days of discharge. Most patients received fragmented care (57.0%). Compared with the continuous care group, the fragmented care group was more likely to have severe chronic lung disease, cerebrovascular disease, and heart failure. States that had lower TAVI volume per Center for Medicare and Medicaid Services population had greater fragmentation. Patients living > 30 minutes from their TAVI center had an increased risk of fragmented care 1.07 (confidence interval [CI] 1.06 to 1.09, p < 0.001). After adjustment for comorbidities and procedural complications, fragmented care was associated with increased 1-year mortality (hazards ratio 1.18, CI 1.04 to 1.35, p = 0.010) and all-cause readmission (hazards ratio 1.08, CI 1.00 to 1.16, p = 0.051. In conclusion, fragmented readmission following TAVI is common, and is associated with increased 1-year mortality and readmission. Efforts to improve coordination of care may improve these outcomes and optimize long-term benefits yielded from TAVI.

Trends and Outcomes of Alternative-Access Transcatheter Aortic Valve Replacement.

BACKGROUND: Alternative access (AA) is still required for a significant proportion of patients undergoing transcatheter aortic valve replacement (TAVR). We sought to compare the clinical outcomes of patients undergoing AA vs transfemoral (TF) access. METHODS: We retrospectively evaluated the outcomes of patients undergoing AA-TAVR between April 2011 and November 2016, and compared them with those who had TF-TAVR. Chi-square and Mann-Whitney U-tests were used to compare the groups and Kaplan-Meier analysis was performed to estimate long-term survival. RESULTS: TAVR was performed in a total of 600 patients, of which 78 (13%) had AA and 522 (87%) had TF access. Patients undergoing AA were younger, and had higher prevalence of chronic obstructive pulmonary disease, peripheral vascular disease, prior myocardial infarction, and prior sternotomy. Greater than mild paravalvular regurgitation (4.2% vs 0.0%; P=.04) and unplanned vascular surgery (5.4% vs 1.3%; P=.09) were more frequent in the TF group. However, patients who underwent AA had longer hospital stay (median 4 days [interquartile range, 3-7 days] vs 3 days [interquartile range, 3-4 days]; P<.001) and an increased incidence of prolonged ventilation (5.1% vs 1.3%; P=.06), 30-day all-cause (5.1% vs 1.7%; P=.08), and cardiovascular mortality (5.1% vs 1.3%; P=.04). The 6-month (15.7% vs 5.7%; P<.01) and 12-month (16.7% vs 10.2%; P=.07) mortality rates were higher for patients undergoing AA. The usage of AA significantly decreased over time (P=.01), primarily driven by a decrease in transapical (P<.001) and direct aortic access (P=.02). CONCLUSIONS: AA-TAVR is associated with an increased incidence of postoperative adverse events, including mortality, when compared with those undergoing TF access.

Identifying the Infarct-Related Artery in Patients With Non-ST-Segment-Elevation Myocardial Infarction.

BACKGROUND: Determining the infarct-related artery (IRA) in non-ST-segment-elevation myocardial infarction (MI) can be challenging. Delayed-enhancement cardiac magnetic resonance (DE-CMR) can accurately identify small MIs. The purpose of this study was to determine whether DE-CMR improves the ability to identify the IRA in patients with non-ST-segment-elevation MI. METHODS AND RESULTS: In this 3-center, prospective study, we enrolled 114 patients presenting with their first MI. Patients underwent DE-CMR followed by coronary angiography. The interventional cardiologist was blinded to the DE-CMR results. Later, coronary angiography and DE-CMR images were reviewed independently and blindly for identification of the IRA. The pattern of DE-CMR hyperenhancement was also used to determine whether there was a nonischemic pathogenesis for myocardial necrosis. The IRA was not identifiable by coronary angiography in 37% of patients (n=42). In these, the IRA or a new noncoronary artery disease diagnosis was identified by DE-CMR in 60% and 19% of patients, respectively. Even in patients with an IRA determined by coronary angiography, a different IRA or a noncoronary artery disease diagnosis was identified by DE-CMR in 14% and 13%, respectively. Overall, DE-CMR led to a new IRA diagnosis in 31%, a diagnosis of nonischemic pathogenesis in 15%, or either in 46% (95% CI, 37%-55%) of patients. Of 55 patients undergoing revascularization, 27% had revascularization solely to nonculprit coronary artery territories as determined by DE-CMR. CONCLUSIONS: Identification of the IRA by coronary angiography can be challenging in patients with non-ST-segment-elevation MI. In nearly half, DE-CMR may lead to a new IRA diagnosis or elucidate a nonischemic pathogenesis. Revascularization solely of coronary arteries that are believed to be nonculprit arteries by DE-CMR is not uncommon.

5-Year Outcomes of Self-Expanding Transcatheter Versus Surgical Aortic Valve Replacement in High-Risk Patients.

BACKGROUND: The CoreValve U.S. Pivotal High Risk Trial was the first randomized trial to show superior 1-year mortality of transcatheter aortic valve replacement (TAVR) compared with surgical aortic valve replacement (SAVR) among high operative mortality-risk patients. OBJECTIVES: The authors sought to compare TAVR to SAVR for mid-term 5-year outcomes of safety, performance, and durability. METHODS: Surgical high-risk patients were randomized (1:1) to TAVR with the self-expanding bioprosthesis or SAVR. VARC-1 (Valve Academic Research Consortium I) definitions were applied. Severe hemodynamic structural valve deterioration was defined as a mean gradient ≥40 mm Hg or a change in gradient ≥20 mm Hg or new severe aortic regurgitation. Five-year follow-up was planned. RESULTS: A total of 797 patients were randomized at 45 U.S. centers, of whom 750 underwent an attempted implant (TAVR = 391, SAVR = 359). The overall mean age was 83 years, and the STS score was 7.4%. All-cause mortality rates at 5 years were 55.3% for TAVR and 55.4% for SAVR. Subgroup analysis showed no differences in mortality. Major stroke rates were 12.3% for TAVR and 13.2% for SAVR. Mean aortic valve gradients were 7.1 ± 3.6 mm Hg for TAVR and 10.9 ± 5.7 mm Hg for SAVR. No clinically significant valve thrombosis was observed. Freedom from severe SVD was 99.2% for TAVR and 98.3% for SAVR (p = 0.32), and freedom from valve reintervention was 97.0% for TAVR and 98.9% for SAVR (p = 0.04). A permanent pacemaker was implanted in 33.0% of TAVR and 19.8% of SAVR patients at 5 years. CONCLUSIONS: This study shows similar mid-term survival and stroke rates in high-risk patients following TAVR or SAVR. Severe structural valve deterioration and valve reinterventions were uncommon. (Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902).

Incidence, Management, and Associated Clinical Outcomes of New-Onset Atrial Fibrillation Following Transcatheter Aortic Valve Replacement: An Analysis From the STS/ACC TVT Registry.

OBJECTIVES: The aim of this study was to evaluate incidence, care patterns, and clinical outcomes in patients developing new-onset atrial fibrillation (AF) following transcatheter aortic valve replacement (TAVR). BACKGROUND: Pre-procedural AF has been associated with adverse outcomes in patients undergoing TAVR, but the incidence of new-onset AF, associated anticoagulant management, and subsequent clinical outcomes are unclear. METHODS: Using the Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry linked with Medicare claims, patients undergoing TAVR from 2011 to 2015 who developed post-procedural AF were evaluated. Patients with known AF prior to TAVR were excluded. Outcomes of interest included in-hospital mortality and stroke and all-cause mortality, stroke, and bleeding at 12 months. Multivariate adjustment was then performed to determine differences in 1-year outcomes among those with and without new post-procedural AF, stratified by anticoagulation status. RESULTS: We identified 1,138 of 13,556 patients (8.4%) who developed new onset AF (4.4% of transfemoral [TF]-access patients, 16.5% of non-TF-access patients). Patients developing AF were older, more likely female, had higher Society of Thoracic Surgeons risk scores, and were often treated using non-TF access. Despite having a median CHA2DS2-VASc score of 5 (25th and 75th percentile: 5 to 6), only 28.9% of patients with new AF were discharged on oral anticoagulation. In-hospital mortality (7.8% vs. 3.4%; p < 0.01) and stroke (4.7% vs. 2.0%; p < 0.01) were higher among patients who developed post-procedural AF compared with those who did not. At 1 year, rates of death (adjusted hazard ratio [HR]: 1.37; 95% confidence interval [CI]: 1.19 to 1.59), stroke (adjusted HR: 1.50; 95% CI: 1.14 to 1.98), and bleeding (adjusted HR: 1.24; 95% CI: 1.10 to 1.40) were higher among patients with new-onset AF. One-year mortality rates were highest among patients who developed new-onset AF but were not discharged on anticoagulation. CONCLUSIONS: Post-TAVR AF occurred in 8.4% of patients (4.4% with TF access, 16.5% with non-TF access), with fewer than one-third of patients receiving anticoagulation at discharge, and was associated with increased risk for in-hospital and 1-year mortality and stroke. Given the clinical significance of post-TAVR AF, additional studies are necessary to delineate the optimal management strategy in this high-risk population.

Stroke and Cardiovascular Outcomes in Patients With Carotid Disease Undergoing Transcatheter Aortic Valve Replacement.

BACKGROUND: Stroke is a serious complication of both transcatheter aortic valve replacement (TAVR) and carotid artery disease (CD). The implications of CD in patients undergoing TAVR are unclear. METHODS AND RESULTS: The Society of Thoracic Surgeons and American College of Cardiology Transcatheter Valve Therapies Registry, consisting of data from consecutive US TAVR cases during the years 2013 to 2015, was linked to Medicare claims data to ascertain 30-day and 1-year cumulative incidence rates of stroke and all-cause mortality. We compared 30-day and 1-year stroke and mortality outcomes between patients with no-CD and patients with moderate, severe, and occlusive CD and adjusted for baseline covariates using proportional hazards models. Among 29 143 patients undergoing TAVR across 390 US sites, 22% had CD. Patients with CD had higher rates of prior hypertension, diabetes mellitus, stroke, and myocardial infarction. Observed in-hospital stroke rates were 2.0% among no-CD, 2.5% among moderate CD, 3.0% among severe CD, and 2.6% among occlusive CD. There was no association between the presence of CD and 30-day stroke (adjusted hazard ratio, 1.16; 95% confidence interval, 0.94-1.43) or mortality (adjusted hazard ratio, 1.10; 95% confidence interval, 0.95-1.28). There was no association between CD and 1-year stroke (adjusted hazard ratio, 1.03; 95% confidence interval, 0.86-1.24) or mortality (adjusted hazard ratio, 1.02; 95% confidence interval, 0.93-1.12). Furthermore, there was no significant risk-adjusted association between severity of CD and 30-day or 1-year stroke or mortality. CONCLUSIONS: CD is common among TAVR patients, present in 1 of 5. CD was not associated with an increased risk of stroke or mortality at 30 day or 1 year. Post-TAVR stroke seems to be because of mechanisms other than CD.

Impact of Balloon Predilatation on Hemodynamics and Outcomes After Transcatheter Aortic Valve Implantation With the Self-Expanding CoreValve Prosthesis.

The impact of predilatation (Pre-Dil) on prosthesis hemodynamics and clinical outcomes of subjects who underwent transcatheter aortic valve implantation (TAVI) with a self-expanding prosthesis remains unclear. Two thousand seven hundred twenty-one subjects from the extreme- and high-risk CoreValve Continued Access Study (CAS) were included in the analysis. Subjects who underwent Pre-Dil before TAVI were compared with subjects who underwent TAVI without Pre-Dil. Clinical outcomes included death, stroke, myocardial infarction, acute kidney injury, and new permanent pacemaker implantation. Serial echocardiograms were analyzed to evaluate prosthesis hemodynamics, specifically paravalvular regurgitation, effective orifice area, and mean gradient. Two thousand one hundred eighteen and 603 subjects underwent TAVI with and without Pre-Dil, respectively. Subjects in the Pre-Dil cohort were more commonly male, while subjects in the no Pre-Dil cohort had higher rates of previous stroke and lower mean aortic valve gradients. Outcomes at 30 days were comparable between Pre-Dil and no Pre-Dil subjects, with no significant difference in mortality (5.5% vs 4.3%, p = 0.27), major stroke (2.6% vs 2.2%, p = 0.54), major vascular complications (6.9% vs 8.0%, p = 0.37), major bleeding (24.4% vs 26.1%, p = 0.40), and permanent pacemaker implantation (21.3% vs 23.4%, p = 0.36). There were no significant differences in the same outcomes at 12 months. Effective orifice area and mean gradient were comparable between Pre-Dil and no-Pre-Dil subjects at discharge, at 30 days, and at 12 months. In conclusion, when performing TAVI with the self-expanding CoreValve device, performing direct implantation without Pre-Dil maintains an acceptable safety profile and still achieves desired and consistent prosthesis hemodynamics.

Peripheral Artery Disease and Transcatheter Aortic Valve Replacement Outcomes: A Report From the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Therapy Registry.

BACKGROUND: Peripheral artery disease (PAD) is associated with increased cardiovascular mortality, and PAD risk factors overlap with those for aortic stenosis. The prevalence and outcomes associated with PAD in a population undergoing transcatheter aortic valve replacement (TAVR) are unknown. METHODS AND RESULTS: Using the Society of Thoracic Surgeons/Transcatheter Valve Therapy Registry linked to Medicare claims data, we identified patients ≥65 years old undergoing TAVR from 2011 to 2015. We calculated hazard ratios for 1-year adverse outcomes, including mortality, readmission, and bleeding, for patients with PAD compared with those without, adjusting for baseline characteristics and postprocedure medications. Analyses were performed separately by access site (transfemoral and nontransfemoral). Of 19 660 patients undergoing transfemoral TAVR, 4810 (24.5%) had PAD; 3730 (47.9%) of 7780 patients undergoing nontransfemoral TAVR had PAD. In both groups, patients with PAD were significantly more likely to have coronary and carotid artery diseases. At 1-year follow-up, patients with PAD undergoing TAVR via transfemoral access had a higher incidence of death (16.8% versus 14.4%; adjusted hazard ratio, 1.14; P=0.01), readmission (45.5% versus 42.1%; hazard ratio, 1.11; P<0.001), and bleeding (23.1% versus 19.7%; hazard ratio, 1.18; P<0.001) compared with patients without PAD. Patients with PAD undergoing TAVR via nontransfemoral access did not have significantly higher rates of 1-year mortality or readmission compared with patients without PAD. CONCLUSIONS: PAD is common among patients undergoing commercial TAVR via transfemoral and nontransfemoral access. Among patients undergoing transfemoral TAVR, PAD is associated with a higher incidence of 1-year adverse outcomes compared with absence of PAD. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01737528.