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Objectives This study sought to evaluate cardiac computed tomography (CCT) findings and their clinical impact among patients being considered for transcatheter mitral valve replacement (TMVR). Background CCT is used to evaluate whether patients are candidates for TMVR, but limited data exist on the yield of such tests. Methods Patients referred for pre-procedural CCT for TMVR planning in the context of failing mitral bioprosthetic valves, annuloplasty rings, and severe native valve disease with annular calcification were included in this study. CCT findings were analyzed to evaluate for suitability for TMVR. In the subset of patients who underwent TMVR, echocardiographic and procedural characteristics were recorded. Results Among 80 patients who underwent pre-procedural CCT, the mean age was 71.8 ± 11.4 years, 60% were women, and the mean Society of Thoracic Surgeon score was 9.4 ± 6.7. Most cases were referred for valve-in-native annular calcification planning (n = 43), followed by valve-in-valve (n = 29), and valve-in-ring procedures (n = 8). A total of 51 (64%) patients did not undergo TMVR, 37 of whom had high-risk features identified on CCT. The most common reason for exclusion was related to large annular size, followed by heightened risk of left ventricular outflow tract (LVOT) obstruction. Among 29 patients (36%) who underwent TMVR, the 30-day mortality rate was 17%. Five patients experienced LVOT obstruction, 4 of whom were predicted by CCT. Following TMVR, 5 patients had at least moderate peri-valvular regurgitation. Conclusions A minority of patients referred for TMVR planning ultimately undergo the procedure. CCT identifies unsuitable anatomy and leads to exclusion in a significant number of cases.

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 P 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.

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

The coronavirus disease-2019 (COVID-19) pandemic has strained health care resources around the world, causing many institutions to curtail or stop elective procedures. This has resulted in an inability to care for patients with valvular and structural heart disease in a timely fashion, potentially placing these patients at increased risk for adverse cardiovascular complications, including CHF and death. The effective triage of these patients has become challenging in the current environment, as clinicians have had to weigh the risk of bringing susceptible patients into the hospital environment during the COVID-19 pandemic against the risk of delaying a needed procedure. In this document, the authors suggest guidelines for how to triage patients in need of structural heart disease interventions and provide a framework for how to decide when it may be appropriate to proceed with intervention despite the ongoing pandemic. In particular, the authors address the triage of patients in need of transcatheter aortic valve replacement and percutaneous mitral valve repair. The authors also address procedural issues and considerations for the function of structural heart disease teams during the COVID-19 pandemic.

Coronavirus disease 2019 (COVID-19) has placed an enormous strain on the health care systems of the nations where it has spread widely, with specific implications of the disease on practice in the catheterization laboratory. These implications include how we might modify practice for standard

Background The impact of procedure location on clinical outcomes after TAVR remains unclear. We aimed to compare short-term outcomes in patients undergoing transcatheter aortic valve replacement (TAVR) in the catheterization laboratory (CATH) versus surgical operating room (OR). Methods A retrospective review of 63,581 trans-femoral TAVR patients using balloon-expandable valves from 2015 to 2018 were captured utilizing the TVT Registry. Propensity score matching was performed using 24 covariates resulting in 2 risk-adjusted groups. Patients were further stratified by STS Risk Score with outcomes compared. Results Propensity score matching resulted in 24,160 risk-matched CATH and OR patient pairs. Short-term clinical outcomes including all-cause mortality, stroke, major vascular complications, life-threatening bleeding, and new dialysis were similar between CATH and OR (p = all ns). There was no difference in conversion to open heart surgery between CATH and OR with both occurring at a very low rate (0.4% vs. 0.5%, p = 0.07). Moreover, the 30-day survival post-conversion was similar whether TAVR was performed in CATH versus OR (43.3% and 49.7%, p = 0.28). When stratified by STS Risk Score, there was no difference in conversion to surgery or 30-day mortality in low and intermediate risk patients between CATH and OR. For high risk patients, however, conversion to surgery was lower in CATH vs. OR (0.2% vs. 0.4%, p = 0.04) with no difference in 30-day survival (46% vs. 43%, p = 0.94). Conclusions Procedure location has minimal impact on TAVR procedural and 30-day outcomes with a very low conversion to open surgery rate between CATH versus OR for low, intermediate, and high-risk patients.

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.Recent studies have demonstrated a volume-outcome relationship for TAVR.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.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.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.

Importance There are limited data on outcomes of transcatheter aortic valve replacement (TAVR) for bicuspid aortic stenosis in patients at low surgical risk. Objective To compare the outcomes of TAVR with a balloon-expandable valve for bicuspid vs tricuspid aortic stenosis in patients who are at low surgical risk. Design, setting, and participants Registry-based cohort study of patients undergoing TAVR at 684 US centers. Participants were enrolled in the Society of Thoracic Surgeons (STS)/American College of Cardiology Transcatheter Valve Therapies Registry from June 2015 to October 2020. Among 159 661 patients (7058 bicuspid, 152 603 tricuspid), 37 660 patients (3243 bicuspid and 34 417 tricuspid) who were at low surgical risk (defined as STS risk score Exposures TAVR for bicuspid vs tricuspid aortic stenosis. Main outcomes and measures Coprimary outcomes were 30-day and 1-year mortality and stroke. Secondary outcomes included procedural complications and valve hemodynamics. Results Among 159 661 patients (7058 bicuspid; 152 603 tricuspid), 3168 propensity-matched pairs of patients with bicuspid and tricuspid aortic stenosis at low surgical risk were analyzed (mean age, 69 years; 69.8% men; mean [SD] STS-predicted risk of mortality, 1.7% [0.6%] for bicuspid and 1.7% [0.7%] for tricuspid). There was no significant difference between the bicuspid and tricuspid groups' rates of death at 30 days (0.9% vs 0.8%; hazard ratio [HR], 1.18 [95% CI, 0.68-2.03]; P = .55) and at 1 year (4.6% vs 6.6%; HR, 0.75 [95% CI, 0.55-1.02]; P = .06) or stroke at 30 days (1.4% vs 1.2%; HR, 1.14 [95% CI, 0.73-1.78]; P = .55) and at 1 year (2.0% vs 2.1%; HR 1.03 [95% CI, 0.69-1.53]; P = .89).There were no significant differences between the bicuspid and tricuspid groups in procedural complications, valve hemodynamics (aortic valve gradient: 13.2 mm Hg vs 13.5 mm Hg; absolute risk difference [RD], 0.3 mm Hg [95% CI, -0.9 to 0.3 mm Hg]), and moderate or severe paravalvular leak (3.4% vs 2.1%; absolute RD, 1.3% [95% CI, -0.6% to 3.2%]). Conclusions and relevance In this preliminary, registry-based study of propensity-matched patients at low surgical risk who had undergone TAVR for aortic stenosis, patients treated for bicuspid vs tricuspid aortic stenosis had no significant difference in mortality or stroke at 30 days or 1 year. Because of the potential for selection bias and absence of a control group treated surgically for bicuspid aortic stenosis, randomized trials are needed to adequately assess the efficacy and safety of transcatheter aortic valve replacement for bicuspid aortic stenosis in patients at low surgical risk.

Despite the rapid growth of aortic valve replacement (AVR) for aortic stenosis (AS), limited data suggest symptomatic severe AS remains undertreated.This study sought to investigate temporal trends in AVR utilization among patients with a clinical indication for AVR.Patients with severe AS (aortic valve area 1 cmOf 10,795 patients, 6,150 (57%) had an indication or potential indication for AVR, of whom 2,977 (48%) received AVR. The frequency of AVR varied by AS subtype with LG groups less likely to receive an AVR (HG-NEF: 70%, HG-LEF: 53%, LG-NEF: 32%, LG-LEF: 38%, P 0.001). AVR volumes grew over the 18-year study period but were paralleled by comparable growth in the number of patients with an indication for AVR. In patients with a Class I indication, younger age, coronary artery disease, smoking history, higher hematocrit, outpatient index transthoracic echocardiogram, and LVEF ≥0.5 were independently associated with an increased likelihood of receiving an AVR. AVR was associated with improved survival in each AS-subgroup.Over an 18-year period, the proportion of patients with an indication for AVR who did not receive AVR has remained substantial despite the rapid growth of AVR volumes.

Although multiple studies have examined the clinical aspects of diagnosis, treatment, and management of patients with aortic stenosis (AS), limited data exist regarding patient experiences related to symptoms, diagnosis, treatment, and personal impacts of living with AS.Adults aged ≥40 years diagnosed with AS were recruited and separated into three cohorts: medically managed, surgical aortic valve replacement (SAVR), and transcatheter aortic valve implantation (TAVI). Forty-five semi-structured interviews were conducted (15 per treatment group) via teleconference using open-ended questions and probes. Interview recordings were transcribed, and inductive thematic analyses were conducted.The majority of participants were male (55.6%), White (95.6%), and non-Hispanic (93.3%). Participants noting longer times to diagnosis also reported mild symptom onset and experiences of misdiagnoses. Participants described a strong reliance on their health care professionals (HCPs) to guide them through their treatment decisions, which were influenced by the effects of anticoagulation, future valve interventions, and recovery. Medically managed participants reported having to make lifestyle modifications to manage symptoms, while participants who underwent TAVI or SAVR reported positive sentiments in their ability to return to normal life following their treatment.Due to the varied experiences of AS patients, there is a need to improve patient resources to advance patient understanding and facilitate informed treatment decisions. Reported experiences also indicate a need for additional HCP education on early referral to a multidisciplinary heart valve team.

OBJECTIVES We report the 30-day outcomes from the roll-in cohort of the CLASP IID trial, representing the first procedures performed by each site. BACKGROUND The currently enrolling CLASP IID/IIF pivotal trial is a multicenter, prospective, randomized trial assessing the safety and effectiveness of the PASCAL transcatheter valve repair system in patients with clinically significant MR. The trial allows for up to three roll-in patients per site. METHODS Eligibility criteria were: DMR ≥3+, prohibitive surgical risk, and deemed suitable for transcatheter repair by the local heart team. Trial oversight included a central screening committee and echocardiographic core laboratory. The primary safety endpoint was a 30-day composite MAE: cardiovascular mortality, stroke, myocardial infarction (MI), new need for renal replacement therapy, severe bleeding, and non-elective mitral valve re-intervention, adjudicated by an independent clinical events committee. Thirty-day echocardiographic, functional, and quality of life outcomes were assessed. RESULTS A total of 45 roll-in patients with mean age of 83 years and 69% in NYHA class III/IV were treated. Successful implantation was achieved in 100%. The 30-day composite MAE rate was 8.9% including one cardiovascular death (2.2%) due to severe bleeding from a hemorrhagic stroke, one MI, and no need for re-intervention. MR≤1+ was achieved in 73% and ≤2+ in 98% of patients. 89% of patients were in NYHA class I/II (p

Background: The use of valve-in-valve–transcatheter aortic valve replacement (VIV-TAVR) in degenerated aortic bioprosthesis has been increasing, but the Food and Drug Administration approval is limited to high-risk patients. We analyzed the real-world experience of SAPIEN 3 VIV-TAVR, especially in lower-risk patients, based on the Society of Thoracic Surgeons (STS) score. Methods: All transfemoral VIV-TAVR with the SAPIEN 3 and Ultra valves between June 2015 and January 2020 were identified using the STS/American College of Cardiology Transcatheter Valve Therapies Registry. Patients were grouped based on STS score (low score: 8%). Propensity-matched (1:3) analysis was conducted to compare to patients undergoing native TAVR. Results: Of 145 917 SAPIEN 3 TAVR patients, 4460 (3%) underwent transfemoral VIV-TAVR with available baseline STS data in 4276 patients. Average age was 73.9±11.2, 66.4% were male, and the mean STS score was 6.9±6.0%. Overall 30-day mortality was 2.4% (observed to expected ratio, 0.33), and 1-year mortality was 10.8%. 30-day mortality and observed to expected ratio were 0.9% and 0.32 in low-score, 2.2% and 0.38 in the intermediate-score, and 4.3% and 0.31 in the high-score group. Based on propensity-matched analysis, 30-day mortality was similar and 1-year mortality was lower in VIV compared to native TAVR among all risk groups. When the groups were analyzed based on the Heart Team risk stratification using high-risk and non–high risk, the findings remained consistent. Conclusions: In this real-world study, VIV-TAVR had excellent 30-day and 1-year outcomes, especially in lower-risk patients. These findings may suggest the feasibility and expansion of VIV-TAVR in lower-risk patients. However, long-term follow-up continues to be crucial.

This study sought to determine the safety of the BASILICA (bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction) procedure.Transcatheter aortic valve replacement causes coronary artery obstruction in 0.7% of cases, with 40% to 50% mortality. BASILICA is a procedure to prevent coronary obstruction. Safety and feasibility in a large patient cohort is lacking.The international BASILICA registry was a retrospective, multicenter, real-world registry of patients at risk of coronary artery obstruction undergoing BASILICA and transcatheter aortic valve replacement. Valve Academic Research Consortium-2 definitions were used to adjudicate events.Between June 2017 and December 2020, 214 patients were included from 25 centers in North America and Europe; 72.8% had bioprosthetic aortic valves and 78.5% underwent solo BASILICA. Leaflet traversal was successful in 94.9% and leaflet laceration in 94.4%. Partial or complete coronary artery obstruction was seen in 4.7%. Procedure success, defined as successful BASILICA traversal and laceration without mortality, coronary obstruction, or emergency intervention, was achieved in 86.9%. Thirty-day mortality was 2.8% and stroke was 2.8%, with 0.5% disabling stroke. Thirty-day death and disabling stroke were seen in 3.4%. Valve Academic Research Consortium-2 composite safety was achieved in 82.8%. One-year survival was 83.9%. Outcomes were similar between solo and doppio BASILICA, between native and bioprosthetic valves, and with the use of cerebral embolic protection.BASILICA is safe, with low reported rates of stroke and death. BASILICA is feasible in the real-world setting, with a high procedure success rate and low rates of coronary artery obstruction.

Background: Surgical aortic valve replacement (SAVR) is associated with adverse outcomes in patients with radiation-associated aortic stenosis. Transcatheter aortic valve replacement (TAVR) may improve outcomes in this population. Methods: We evaluated 1668 TAVR and 2611 patients with SAVR enrolled in the Society of Thoracic Surgeons’ database between 2011 and 2018. Multiple logistic regression was used to compare 30- day outcomes between TAVR and SAVR. Propensity-matched analysis was performed to confirm results of the overall cohort. Additionally, the cohort was stratified into early (2011–2014) versus contemporary (2015–2018) TAVR eras, and 30-day outcomes for TAVR and SAVR were compared. Finally, outcomes with transfemoral TAVR versus SAVR were compared. Results: In the overall cohort, TAVR was associated with significantly reduced 30-day mortality (odds ratio [OR] TAVR/SAVR =0.60 [0.40–0.91]). Postoperative atrial fibrillation, pneumonia, pleural effusion, renal failure, and bleeding also occurred less frequently with TAVR. Stroke/transient ischemic attack (TIA; OR TAVR/SAVR , 2.03 [1.09–3.77]) and pacemaker implantation (OR TAVR/SAVR , 1.62 [1.21–2.17]) were higher with TAVR. Propensity-matched analysis yielded similar results as the overall cohort. Following stratification by era, TAVR versus SAVR was associated with reduced 30-day mortality in the contemporary but not early era (OR Early , 0.78 [0.48–1.28]; OR Contemporary , 0.31 [0.14–0.65]). Pacemaker implantation was higher with TAVR versus SAVR in both eras (OR Early , 1.60 [1.03–2.46]; OR Contemporary , 1.64 [1.10–2.45]). There was also a nonsignificant trend towards increased stroke/TIA with TAVR during both eras (OR Early , 1.39 [0.58–3.36]; OR Contemporary , 2.46 [0.99–6.10]). Finally, transfemoral TAVR (N=1369) versus SAVR revealed similar findings as the overall cohort; however, the association of TAVR with stroke/TIA was not statistically significant (OR Stroke/TIA , 1.57 [0.79–3.09]). Conclusions: TAVR provides an effective and evolving alternative to SAVR for radiation-associated severe aortic stenosis and was associated with lower 30-day mortality and postoperative complications. TAVR was associated with increased pacemaker implantation and a trend towards increased stroke/TIA. In this unique population with extensive valvular and vascular calcifications, the risk of stroke/TIA with TAVR requires careful consideration and further investigation.

The field of interventional cardiology has expanded rapidly. As a result, four evolving areas have evolved - peripheral vascular interventions, structural heart interventions, adult congenital heart intervention, and chronic total occlusion. The complexity of these procedures and the number of devices available has grown rapidly. In addition, the professional and public expectations of procedural success and of minimizing case-avoidance have also grown. Specific issues include volume-outcome relationships, maintaining currency and proficiency, accessibility to specialized procedures, and the need to maintain a fundamental level of expertise in acute coronary interventions.

Background Given the recent growth in the number of MitraClip procedures in patients with functional mitral regurgitation (MR), there is interest in an echocardiographic index to predict technical success before intervention. We investigated the utility of a novel leaflet coaptation index (LCI) to predict outcomes after MitraClip in functional MR patients. Methods Forty consecutive patients with functional MR who underwent MitraClip were included. The LCI was defined as the coapted leaflet length divided by the anteroposterior diameter of the mitral annulus. The coapted leaflet length was calculated by separately tracing the total length of the mitral valve leaflets at early and end systole on transesophageal echocardiography. The primary endpoint was defined as residual MR ≥ moderate after MitraClip. Results The LCI was significantly associated with residual MR ≥ moderate (odds ratio, 0.827; 95% confidence interval, 0.696-0.982; p = .030) with the cut-off LCI value of 0.14 (sensitivity 70.4%, specificity 69.2%, c-statistic 0.815; p = .001). Conclusion This novel index may be a useful adjunct that can be incorporated into the armamentarium of contemporary clinical performance risk prediction tools for MitraClip success.

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.

Background: Transcatheter mitral valve replacement using aortic transcatheter heart valves has recently become an alternative for patients with degenerated mitral bioprostheses, failed surgical repairs with annuloplasty rings or severe mitral annular calcification who are poor surgical candidates. Outcomes of these procedures are collected in the Society of Thoracic Surgeons/American College of Cardiology/Transcatheter Valve Therapy Registry. A comprehensive analysis of mitral valve-in-valve (MViV), mitral valve-in-ring (MViR), and valve-in-mitral annular calcification (ViMAC) outcomes has not been performed. We sought to evaluate short-term outcomes of early experience with MViV, MViR, and ViMAC in the United States. Methods: Retrospective analysis of data from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. Results: Nine hundred three high-risk patients (median Society of Thoracic Surgeons score 10%) underwent MViV (n=680), MViR (n=123), or ViMAC (n=100) between March 2013 and June 2017 at 172 hospitals. Median age was 75 years, 59.2% female. Technical and procedural success were higher in MViV. Left ventricular outflow tract obstruction occurred more frequently with ViMAC (ViMAC=10%, MViR=4.9%, MViV=0.7%; P P =0.004) and 30-day mortality (MViV=8.1%, MViR=11.5%, ViMAC=21.8%; P =0.003) were higher in ViMAC. At 30-day follow-up, median mean mitral valve gradient was 7 mm Hg, most patients (96.7%) had mitral regurgitation grade ≤1 (+) and were in New York Heart Association class I to II (81.7%). Conclusions: MViV using aortic balloon-expandable transcatheter heart valves is associated with a low complication rate, a 30-day mortality lower than predicted by the Society of Thoracic Surgeons score, and superior short-term outcomes than MViR and ViMAC. At 30 days, patients in all groups experienced improvement of symptoms, and valve performance remained stable. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02245763.

Objectives: The aim of this study was to evaluate the impact of initial deployment orientation of SAPIEN 3, Evolut, and ACURATE-neo transcatheter heart valves on their final orientation and neocommissural overlap with coronary arteries. Background: Coronary artery access and redo transcatheter aortic valve replacement (TAVR) following initial TAVR may be influenced by transcatheter heart valve orientation. In this study the impact of transcatheter heart valve deployment orientation on commissural alignment was evaluated. Methods: Pre-TAVR computed tomography and procedural fluoroscopy were analyzed in 828 patients who underwent TAVR (483 SAPIEN 3, 245 Evolut, and 100 ACURATE-neo valves) from March 2016 to September 2019 at 5 centers. Coplanar fluoroscopic views were coregistered to pre-TAVR computed tomography to determine commissural alignment. Severe overlap between neocommissural posts and coronary arteries was defined as 0° to 20° apart. The SAPIEN 3 had 1 commissural post crimped at 3, 6, 9, and 12 o'clock. The Evolut “Hat” marker and ACURATE-neo commissural post at deployment were classified as center back (CB), inner curve (IC), outer curve (OC), or center front (CF) and matched with final orientation. Results: Initial SAPIEN 3 crimped orientation had no impact on commissural alignment. Evolut “Hat” at OC or CF at initial deployment had less severe overlap than IC or CB (p < 0.001) against the left main (15.7% vs. 66.0%) and right coronary (7.1% vs. 51.1%) arteries. Tracking Evolut “Hat” at OC of the descending aorta (n = 107) improved OC at deployment from 70.2% to 91.6% (p = 0.002) and reduced coronary artery overlap by 36% to 60% (p < 0.05). ACURATE-neo commissural post at CB or IC during deployment had less coronary artery overlap compared to CF or OC (p < 0.001), with intentional alignment successful in 5 of 7 cases. Conclusions: This is the first systematic evaluation of commissural alignment in TAVR. More than 30% to 50% of cases had overlap with 1 or both coronary arteries. Initial SAPIEN 3 orientation had no impact on alignment, but specific initial orientations of Evolut and ACURATE improved alignment. Optimizing valve alignment to avoid coronary artery overlap will be important in coronary artery access and redo TAVR.

Importance Impaired myocardial flow reserve (MFR) and stress myocardial blood flow (MBF) on positron emission tomography (PET) myocardial perfusion imaging may identify adverse myocardial characteristics, including myocardial stress and injury in aortic stenosis (AS). Objective To investigate whether MFR and stress MBF are associated with LV structure and function derangements, and whether these parameters improve after aortic valve replacement (AVR). Design, setting, and participants In this single-center prospective observational study in Boston, Massachusetts, from 2018 to 2020, patients with predominantly moderate to severe AS underwent ammonia N13 PET myocardial perfusion imaging for myocardial blood flow (MBF) quantification, resting transthoracic echocardiography (TTE) for assessment of myocardial structure and function, and measurement of circulating biomarkers for myocardial injury and wall stress. Evaluation of health status and functional capacity was also performed. A subset of patients underwent repeated assessment 6 months after AVR. A control group included patients without AS matched for age, sex, and summed stress score who underwent symptom-prompted ammonia N13 PET and TTE within 90 days. Exposures MBF and MFR quantified on ammonia N13 PET myocardial perfusion imaging. Main outcomes and measures LV structure and function parameters, including echocardiographic global longitudinal strain (GLS), circulating high-sensitivity troponin T (hs-cTnT), N-terminal pro-B-type natriuretic peptide (NT-pro BNP), health status, and functional capacity. Results There were 34 patients with AS (1 mild, 9 moderate, and 24 severe) and 34 matched control individuals. MFR was independently associated with GLS and LV ejection fraction, (β,-0.31; P = .03; β, 0.41; P = .002, respectively). Stress MBF was associated with hs-cTnT (unadjusted β, -0.48; P = .005) and log NT-pro BNP (unadjusted β, -0.37; P = .045). The combination of low stress MBF and high hs-cTnT was associated with higher interventricular septal thickness in diastole, relative wall thickness, and worse GLS compared with high stress MBF and low hs-cTnT (12.4 mm vs 10.0 mm; P = .008; 0.62 vs 0.46; P = .02; and -13.47 vs -17.11; P = .006, respectively). In 9 patients studied 6 months after AVR, mean (SD) MFR improved from 1.73 (0.57) to 2.11 (0.50) (P = .008). Conclusions and relevance In this study, in AS, MFR and stress MBF were associated with adverse myocardial characteristics, including markers of myocardial injury and wall stress, suggesting that MFR may be an early sensitive marker for myocardial decompensation.

Leaflet thrombosis is currently one of the greatest concerns related to transcatheter aortic valve replacement (TAVR). Symptomatic valve thrombosis is a rare occurrence, but reduced leaflet motion, diagnosed by computed tomography, seems to be a more common finding [(1)][1]. We screened our

Importance Questions have recently arisen as to whether 30-day mortality is a reasonable metric for understanding institutional practice differences after transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR). Objective To examine the utility of 30-day vs 90-day mortality after TAVR and SAVR as a mortality quality metric. Design, Setting, and Participants This nationally representative, multicenter, cohort study analyzed data from Medicare beneficiaries undergoing TAVR and SAVR procedures from January 1, 2012, to December 31, 2015. Concomitant coronary artery bypass grafting and other heart valve or other major open-heart procedures were excluded. Hospitals that performed fewer than 50 TAVR or 70 SAVR procedures per year were excluded to ensure reliable estimates and to reduce the risks of inflated results because of small institutional sample sizes. Data were analyzed from October 2018 to August 2019. Exposures Hospitals were ranked into top- (10%), middle- (80%), and bottom-performing (10%) groups based on their 4-year mean 30-day mortality. Main Outcomes and Measures Changes in hospital performance rankings at 90 days and 1 year and correlation of 30- and 90-day mortality with 1-year mortality were examined. Results A total of 30 329 TAVR admissions at 184 hospitals and 26 021 SAVR admissions at 191 hospitals were evaluated. For TAVR, 40 hospitals (21.7%) changed performance rankings at 90 days: 13 (48.1%) in the top-performing group and 8 (29.6%) in the bottom-performing group. At 1 year, 56 hospitals (30.4%), which included 21 (77.8%) in the top-performing group and 12 (44.4%) in the bottom-performing group, changed rankings. Similar findings were observed for SAVR, with an overall 90-day conversion rate of 17.3% and a 1-year rate of 30.3%. These findings persisted after adjusting for the differences in patient risk profiles among the 3 groups. Capturing 90-day events was also more robustly informative regarding expected 1-year outcomes after both TAVR and SAVR, largely owing to the observed plateau in the instantaneous hazard observed beyond this point. Conclusions and Relevance The findings suggest that evaluation of hospital performance based on 30-day mortality may underestimate outcomes and therefore substantially misrepresent institutional performance after TAVR and SAVR compared with 90-day mortality, even after risk adjustment. Although 30-day mortality has been validated, 90-day mortality may be a more reliable outcome metric for measuring hospital performance and capturing procedure-related mortality.

Aortic stenosis (AS) management is classically guided by symptoms and valvular metrics. However, the natural history of AS is dictated by coupling of the left ventricle, aortic valve, and vascular system. We investigated whether metrics of ventricular and vascular state add to the appreciation of AS state above valve gradient alone. Seventy patients with severe symptomatic AS were prospectively followed from baseline to 30 days after transcatheter aortic valve replacement (TAVR). Quality of life (QOL) was assessed using the Kansas City Cardiomyopathy Questionnaire. Left ventricular stroke work (SW[subscript LV]) and vascular impedance spectrums were calculated noninvasively using in-house models based on central blood pressure waveforms, along with hemodynamic parameters from echocardiograms. Patients with higher preprocedural SW[subscript LV] and lower vascular impedance were more likely to experience improved QOL after TAVR. Patients fell into two categories: those who did and those who did not exhibit increase in blood pressure after TAVR. In patients who developed hypertension (19%), vascular impedance increased and SW[subscript LV] remained unchanged (impedance at zeroth harmonic: Z[subscript 0], from 3964.4 to 4851.8 dyne·s/cm[superscript 3], P = 0.039; characteristic impedance: Z[subscript c], from 376.2 to 603.2 dyne·s/cm[superscript 3], P = 0.033). SW[subscript LV] dropped only in patients who did not develop new hypertension after TAVR (from 1.58 to 1.26 J; P < 0.001). Reduction in valvular pressure gradient after TAVR did not predict change in SW[subscript LV] (r = 0.213; P = 0.129). Reduction of SW[subscript LV] after TAVR may be an important metric in management of AS, rather than relying solely on the elimination of transvalvular pressure gradients.

Objectives This paper details trends and outcomes in U.S. patients undergoing transcatheter aortic valve replacement (TAVR) who present pre-procedurally with cardiogenic shock. Background Demographic, procedural characteristics, and clinical outcomes in U.S. patients undergoing TAVR after presenting with cardiogenic shock are unknown. Methods The STS/ACC TVT (Society of Thoracic Surgeons and the American College of Cardiology Transcatheter Valve Therapy) registry linked with Centers for Medicare & Medicaid Services claims data was used to identify patients between 2014 and 2017 who presented with cardiogenic shock before TAVR in comparison to a high-risk cohort that did not present with cardiogenic shock. The primary outcome of interest was 30-day mortality. Secondary outcomes included 30-day procedural complications. Results Presentations with cardiogenic shock currently represent 4.1% of the U.S. TAVR population. A total of 2,220 patients with acute cardiogenic shock undergoing TAVR (median STS 9.8) were compared with 12,851 high-risk patients (median STS 10.2). Cardiogenic shock was associated with higher 30-day mortality (19.1% vs. 4.9%) and higher rates of complications. The absence of 30-day major complications was not associated with a marked reduction in 30-day mortality, and overall procedural success rates were high. The risk of death from acute cardiogenic shock before TAVR was strongly related to the degree of shock pre-procedure. Conclusions TAVR appears to be a viable treatment option for patients presenting with aortic stenosis and acute cardiogenic shock. Although procedural success is high, this population remains at an elevated risk of death, which appears to be mostly driven by the degree of pre-procedural shock.

Objectives The aim of this study was to report the 1-year results of transcatheter aortic valve replacement (TAVR) with the Edwards SAPIEN 3 (S3) valve in extremely large annuli. Background Favorable 30-day outcomes of S3 TAVR in annuli >683 mm2 have previously been reported. Pacemaker implantation rates were acceptable, and a larger left ventricular outflow tract and more eccentric annular anatomy were associated with increasing paravalvular leak. Methods From December 2013 to December 2018, 105 patients across 15 centers with mean area 721.3 ± 36.1 mm2 (range: 683.5 to 852.0 mm2) underwent TAVR using an S3 device. Clinical, anatomic, and procedural characteristics were analyzed. One-year survival and echocardiographic follow-up were reached in 94.3% and 82.1% of patients, respectively. Valve Academic Research Consortium-2 30-day and 1-year outcomes were reported. Results The mean age was 76.9 ± 10.4 years, and Society of Thoracic Surgeons predicted risk score averaged 5.2 ± 3.4%. One-year overall mortality and stroke rates were 18.2% and 2.4%, respectively. Quality-of-life index improved from baseline to 30 days and at 1 year (p Conclusions S3 TAVR in annular areas >683 mm2 is feasible, with favorable mid-term outcomes.

We investigated role of coronary microvascular disease (CMD) in maladaptive LV remodeling and prognosis in patients with aortic sclerosis or stenosis and no overt CAD. This was a retrospective cohort study of patients with aortic sclerosis or stenosis, normal myocardial perfusion and LV ejection fraction (EF) > 50% (n = 43) and matched controls without AS (n = 43). PET and echocardiograms were performed within 1 year of each other. Myocardial perfusion and myocardial flow reserve (MFR) were quantified using PET imaging. LV structure and function, including global longitudinal strain (GLS), were quantified by transthoracic echocardiography. Global MFR declined with increasing AS severity (P = 0.04). Probability of impaired MFR increased with severity of adverse LV remodeling (OR 1.88, CI 1.03 to 3.41, P =0.04). Reduced MFR associated with impaired GLS (r = − 0.29, P = 0.002) and associated with reduced MACE-free survival at 7.27 years median follow-up. Adjusted annualized rate of MACE was highest in those with impaired GLS and MFR and lowest in those with normal GLS and MFR (30.99% vs 1.86%, P =0.002). In patients with AS and no overt CAD, impaired MFR associates with adverse LV remodeling and subclinical LV mechanical dysfunction, and is a marker increased clinical risk.

Background Bioprosthetic aortic valve use has increased steadily according to The Society of Thoracic Surgeons (STS) database analyses. One of the momentums toward this trend is the future utilization of transcatheter valve-in-valve (TViV) techniques when bioprosthetic valves fail. We compared the results of reoperative TViV to surgical aortic valve replacement (SAVR) for degenerated bioprosthetic valves. Methods From January 2002 to January 2015, we identified 91 patients with degenerated bioprosthetic valves who underwent isolated AVR (SAVR n = 69, TViV n = 22). Patients with prior homografts or active endocarditis were excluded. The STS risk score was used to create 22 matched pairs of SAVR and TViV for comparison. Results Before matching, mean STS risk scores were 4.36 ± 3.1 and 7.54 ± 3.0 for SAVR and TViV, respectively ( p = 0.001), but were 7.70 ± 3.4 and 7.54 ± 3.0, respectively ( p = 0.360), after matching. Mean age was 74.5 ± 10.4 years for SAVR and 75.0 ± 9.6 years for TViV ( p = 0.749). Operative mortality was 4.3% (1 of 22) in the SAVR group and zero for TViV ( p = 1.00). Mean postoperative gradient was 13.5 ± 13.2 mm Hg for SAVR and 12.4 ± 6.2 mm Hg for TViV ( p = 0.584). There was no coronary obstruction in either group, but 22% of TViV (5 of 22) had mild paravalvular leaks versus none in the SAVR group ( p = 0.048). Postoperative stroke rate was 9% (2 of 22) for SAVR and zero for TViV ( p = 0.488). The TViV group had shorter median length of stay (5 versus 11 days, p = 0.001). Actuarial survival at 3 years was 76.3% (95% confidence interval: 58.1 to 94.5) versus 78.7 (95% confidence interval: 56.2 to 100) for SAVR and TViV, respectively ( p = 0.410). Conclusions For degenerated bioprosthetic aortic valves, TViV has similar operative mortality, strokes rates, and survival as SAVR in this high-risk cohort. Therefore, TViV is a viable alternative to SAVR, although studies using registry data are needed to establish noninferiority.

Access options for transcatheter aortic valve replacement (TAVR) currently include transfemoral, transaortic, transapical, transsubclavian, and other approaches. Transsubclavian access for balloon expandable valves is gaining popularity when transfemoral access is not suitable, given its peripheral access compared with central access. With the transsubclavian approach, second femoral or radial artery access is necessary for pigtail catheter placement. We describe a "double-stick" transsubclavian technique that eliminates secondary arterial access. With this technique, the transsubclavian approach can still be used in patients with advanced femoral disease, and it allows for rapid ambulation in most patients.

Left ventricular outflow tract obstruction (LVOTO) is a potentially devastating complication of transcatheter mitral valve interventions [(1)][1]. During mitral valve-in-valve (MViV) procedures, superimposition of a transcatheter valve into the existing surgical bioprosthetic mitral valve creates

A lower rate of permanent pacemaker (PPM) has been linked to a target aortic implantation height (AIH)0.70, following transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 valve. Based on clinical experience, it was hypothesized that a higher AIH (≥0.85) would lower the rate of PPM implantation.A total of 127 patients (66 females, 61 males; mean age 82 ± 8 years) underwent TAVR with the SAPIEN 3 valve between May 2015 and July 2016. AIH was defined as the proportion of the valve frame above the aortic annulus in the post-deployment aortogram. A target AIH (≥0.70) was achieved in 113 patients (89%). Cases were stratified into a High Implantation (HI) group (AIH ≥0.85; 33 patients) or a Standard Implantation (SI) group (AIH0.85; 94 patients).The mean Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) score of all patients was 6.4 ± 3.5%. Preoperative right bundle branch block (RBBB) was prevalent in 13% of SI patients, and in 18% of HI patients (p = 0.56). There were no significant differences in operative mortality (3.2% versus 0%), median length of stay (2 days versus 3 days) and incidence of moderate-to-severe paravalvular leak (3.2% versus 0%; all p0.410) between SI and HI patients, respectively. Likewise, the incidence of new PPM did not differ between the two groups (12% in HI versus 13% in SI; p ≥0.99). The mean AIH was similar for patients with PPM implantation (0.80 ± 0.08) compared to those without (0.78 ± 0.06; p = 0.520). Preoperative RBBB was significantly associated with PPM implantation (odds ratio (OR) 10.1; p = 0.002), and patients who underwent PPM implantation had a higher operative mortality (12.5% versus 1%; p = 0.040).Among TAVR patients who received the SAPIEN 3 heart valve, a higher AIH (≥0.85) was not associated with a lower rate of PPM implantation or increased operative mortality. Prior RBBB was the only independent risk factor for new PPM implantation. Long-term follow up is crucial in determining the clinical significance of PPM implantation.

Objectives The aim of this study was to determine factors affecting paravalvular leak (PVL) in transcatheter aortic valve replacement (TAVR) with the Edwards SAPIEN 3 (S3) valve in extremely large annuli. Background The largest recommended annular area for the 29-mm S3 is 683 mm2. However, experience with S3 TAVR in annuli >683 mm2 has not been widely reported. Methods From December 2013 to July 2017, 74 patients across 16 centers with mean area 721 ± 38 mm2 (range: 684 to 852 mm2) underwent S3 TAVR. The transfemoral approach was used in 95%, and 39% were under conscious sedation. Patient, anatomic, and procedural characteristics were retrospectively analyzed. Valve Academic Research Consortium–2 outcomes were reported. Results Procedural success was 100%, with 2 deaths, 1 stroke, and 2 major vascular complications at 30 days. Post-dilatation occurred in 32%, with final balloon overfilling (1 to 5 ml extra) in 70% of patients. Implantation depth averaged 22.3 ± 12.4% at the noncoronary cusp and 20.7 ± 9.9% at the left coronary cusp. New left bundle branch block occurred in 17%, and 6.3% required new permanent pacemakers. Thirty-day echocardiography showed mild PVL in 22.3%, 6.9% moderate, and none severe. There was no annular rupture or coronary obstruction. Mild or greater PVL was associated with larger maximum annular and left ventricular outflow tract (LVOT) diameters, larger LVOT area and perimeter, LVOT area greater than annular area, and higher annular eccentricity. Conclusions TAVR with the 29-mm S3 valve beyond the recommended range by overexpansion is safe, with acceptable PVL and pacemaker rates. Larger LVOTs and more eccentric annuli were associated with more PVL. Longer term follow-up will be needed to determine durability of S3 TAVR in this population.

A 65-year-old female underwent coronary artery bypass grafting plus mitral valve replacement (MVR) with a 25-mm Epic bioprosthesis (Abbott, Santa Ana, CA). Postoperatively, she was readmitted with congestive heart failure exacerbation. Transthoracic echocardiogram showed mean prosthetic gradient of 18 mm Hg raising concern for early valve deterioration. She was deemed high risk for surgery. Therefore, transseptal transcatheter valve-in-valve MVR with a 23-mm Sapien3 valve (Edwards Lifesciences, Irvine, CA) was performed 15 months post-MVR. Postimplantation …

A 69-year-old woman with a history of coronary artery bypass grafting, preserved ejection fraction, and severe symptomatic aortic stenosis was deemed intermediate risk for surgical aortic valve replacement at our institution. The patient and her family expressed a strong desire for transcatheter therapy compared with open surgery, and she, therefore, underwent uncomplicated transfemoral transcatheter aortic valve replacement with a 23-mm Edwards Sapien 3 valve. Post-dilation of the valve was performed for mild paravalvular leak with reduction in the paravalvular leak to trace. Intraprocedural ACT was 252 seconds, and a clopidogrel load was administered …

Although the incidence of mitral stenosis has declined precipitously in the Western world due to the reduced incidence of rheumatic heart disease, mitral regurgitation remains one of the most common valvular pathologies.[1][1] Many patients affected by severe mitral valve disease are elderly with

Although chronic total occlusion (CTO) of a coronary artery is a common finding,1 there is little consensus as to whether such lesions should be treated routinely by percutaneous coronary intervention (PCI). Benefits of successful CTO PCI include relief of symptoms, resolution of ischemia, improvement in left ventricular function, and avoidance of coronary bypass surgery.2 Conversely, unsuccessful CTO PCI is common, and there are several potential adverse consequences associated with attempting PCI of a CTO. Early in the learning curve, procedures tend to be longer with increased contrast and radiation exposure to the patient.3,4 Coronary perforation is also more frequent with CTO attempts than non-CTO lesions and may be associated with cardiac tamponade, need for emergency surgery, and death.5 Rates of successful CTO are variable and highly dependent on operator skill and experience. Traditional technical success rates range between 60% and 75%,2,6 much lower than rates for non-CTO lesions. In the current era, however, with contemporary techniques and with operators with expertise in CTO PCI, success rates of 80% to 90% have been achieved.5,7 Lack of success can be attributed to procedural challenges that are specific to CTO, and accordingly, approaches unique to coronary CTO PCI have been developed. The major barrier is the inability to traverse the occluded segment with a guidewire because the composition of a CTO includes fibrotic, calcified tissue with no well-defined lumen. CTO PCI requires different equipment compared with standard PCI. Large lumen guide catheters together with extra long sheaths are essential to provide sufficient backup support.8 A unique aspect of CTO PCI is the intentional use the extraluminal space of the obstructed coronary artery to gain …

Background:Kawasaki disease is an acute vasculitis of childhood that leads to coronary artery aneurysms in ≈25% of untreated cases. It has been reported worldwide and is the leading cause of acquired heart disease in children in developed countries.Methods and Results:To revise the previous American Heart Association guidelines, a multidisciplinary writing group of experts was convened to review and appraise available evidence and practice-based opinion, as well as to provide updated recommendations for diagnosis, treatment of the acute illness, and long-term management. Although the cause remains unknown, discussion sections highlight new insights into the epidemiology, genetics, pathogenesis, pathology, natural history, and long-term outcomes. Prompt diagnosis is essential, and an updated algorithm defines supplemental information to be used to assist the diagnosis when classic clinical criteria are incomplete. Although intravenous immune globulin is the mainstay of initial treatment, the role for additional primary therapy in selected patients is discussed. Approximately 10% to 20% of patients do not respond to initial intravenous immune globulin, and recommendations for additional therapies are provided. Careful initial management of evolving coronary artery abnormalities is essential, necessitating an increased frequency of assessments and escalation of thromboprophylaxis. Risk stratification for long-term management is based primarily on maximal coronary artery luminal dimensions, normalized asZscores, and is calibrated to both past and current involvement. Patients with aneurysms require life-long and uninterrupted cardiology follow-up.Conclusions:These recommendations provide updated and best evidence-based guidance to healthcare providers who diagnose and manage Kawasaki disease, but clinical decision making should be individualized to specific patient circumstances.

Surgical aortic valve replacement (SAVR) in patients with porcelain aorta is considered a high-risk procedure. Hence, transcatheter aortic valve implantation (TAVI) is emerging as the intervention of choice. However, there is a paucity of data directly comparing TAVI with SAVR in patients with porcelain aorta. We compared outcomes of TAVI versus SAVR in high-risk patients with porcelain between March 2012 and June 2015. The TAVI group included 54 patients, whereas 130 SAVR patients with porcelain aorta were identified (operated on between 2004 and 2015). Both groups were matched 1:1 based on the Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) score with a 0.5% a priori caliper, resulting in 52 matched pairs. The mean STS-PROM was 7.3 ± 3.9 for both groups (p = 0.98), whereas mean age was 77.5 years for TAVI and 78.8 years for SAVR (p = 0.46). Compared with SAVR, TAVI patients had lower operative mortality (3.8% vs 17.3%; p = 0.052), significantly shorter median intensive care unit (40 vs 107 hours; p 0.001) and hospital (5 vs. 7 days; p 0.001) length of stay (LOS), but similar postoperative stroke rates (7.7% vs 11.5%; p = 0.74). One-year unadjusted survival was 81.7% (95% confidence interval [CI]: 69.8% to 93.5%) in the TAVI group versus 71.2% (95% CI: 61.0% to 85.1%) in the SAVR group, p = 0.093. Cox proportional hazard modeling identified preoperative chronic kidney disease (hazard ratio: 2.63 [95% CI: 1.03 to 6.70]; p = 0.043) and SAVR (hazard ratio: 2.641 [95% CI: 1.07 to 6.51]; p = 0.035) as significant predictors for decreased survival. Overall, TAVI was associated with reduced operative mortality, increased survival, and shorter intensive care unit and hospital length of stay compared with SAVR in patients with porcelain aorta. This study demonstrates that TAVI is a safe intervention in this high-risk population.

A 65-year-old woman underwent transseptal transcatheter mitral valve-in-valve replacement (TMVR) with a 29-mm SAPIEN 3 valve (Edwards Lifesciences, Irvine, California). A hand-curved, Amplatz Super-Stiff wire (Boston Scientific, Marlborough, Massachusetts) was used for valve delivery. She was

In-stent restenosis (ISR) remains a concern even in the drug-eluting stent (DES) era and carries a high risk of recurrence. Brachytherapy is being used as an alternative treatment for resistant ISR, yet the safety and efficacy of this approach has not been well studied. We analyzed the outcomes of 101 patients who underwent coronary brachytherapy for resistant DES ISR. Baseline demographic, clinical, procedural, and outcome data were collected by phone and from electronic records. Comorbidities and overt cardiovascular disease were highly prevalent. Median previous stent layers were 2 with a maximum of 5 layers. Procedural angiographic success rate was 97% and median time to discharge was 1 day after brachytherapy. The primary outcome of target vessel revascularization was 24% at 1 year, 32% at 2 years, and 42% at 3 years. The rate of nonfatal myocardial infarction was 0% at 1 year, 3.5% at 2 years, and 6% at 3 years. The rate of all-cause mortality was 8.5% at 1 year, 12% at 2 years, and 16% at 3 years. We observed only 1 case of late stent thrombosis. After multivariable adjustment, female gender (hazard ratio 2.37, 95% confidence interval 1.02 to 5.52, p = 0.04) and diffuse ISR pattern (hazard ratio 2.95, 95% confidence interval 1.21 to 7.17, p = 0.01) were independently associated with the primary outcome. In conclusion, brachytherapy is feasible for the treatment of resistant DES ISR and is associated with high immediate procedural success and reasonable efficacy in a complex patient population. This approach might be used as an alternative for these patients.

Background Patients with severe pulmonary arterial hypertension (PAH) face significant morbidity and death as a consequence of progressive right heart failure. Surgical shunt placement between the left PA and descending aorta (Potts shunt) appears promising for PAH palliation in children; however, surgical mortality is likely to be unacceptably high in adults with PAH. Methods We describe a technique for transcatheter Potts shunt (TPS) creation by fluoroscopically guided retrograde needle perforation of the descending aorta at the site of apposition to the left PA to create a tract for deployment of a covered stent between these vessels. This covered stent—anchored by the vessel walls and surrounding tissue—serves as the shunt. Results TPS creation was considered in 7 patients and performed in 4. The procedure was technically successful in 3 patients; 1 patient died during the procedure as a result of uncontrolled hemothorax. One acute survivor, critically ill at the time of TPS creation, later died of comorbidities. The 2 mid-term survivors (follow-up of 10 and 4 months) are well at home, with symptomatic improvement and no late complications. The 3 candidate patients in whom the procedure was not performed died within 1 month of consideration, underscoring the tenuous nature of this population. Conclusions TPS creation is feasible and may offer symptomatic relief to select patients with refractory PAH. Further study of this innovative approach is warranted.

Background: We aimed to compare periprocedural transesophageal echocardiography (TEE) with postprocedural transthoracic echocardiography (TTE) for the diagnosis of aortic regurgitation (AR). Methods and Results: TEE and TTE images of 163 transcatheter aortic valve replacement (TAVR) patients (mean age 81 ± 8 years; 56% men) were reviewed separately and blinded to each other as well as to all clinical data. The median time between TEE during TAVR (TEE/TAVR) and TTE was 4 days (IQR 2-10 days). After TAVR, 48% of the patients had at least trace AR by TEE, 56% by angiography and 67% by TTE. The majority of AR was paravalvular (78%). More patients were classified with mild-to-moderate AR by TTE than by TEE (44 vs. 22%, p < 0.01). When examining the 46 patients with AR by TTE which was not at TEE/TAVR, both systolic and diastolic blood pressure (SBP and DBP) were significantly higher during TTE than during TEE (mean ΔSBP = 9 ± 4 mm Hg and mean ΔDBP = 6 ± 2 mm Hg, p < 0.01 for both). No differences in BP between TEE and TTE were found among patients with no AR or among those who had AR in both studies. At a median follow-up of 185 days (IQR 39-424 days), the overall mortality was 17%, but this was not associated with the presence of AR on TTE or TEE. Conclusions: Patients' hemodynamic conditions may result in underdiagnosis of paravalvular regurgitation in periprocedural TEE. Our findings suggest that a postprocedural evaluation for AR by TTE could serve as a reasonable alternative to TEE for the evaluation of AR.

A variety of access routes have been employed for transcatheter aortic valve replacement (TAVR). We report a TAVR case using the abdominal aorta as the direct access route when other approaches are not feasible.

OBJECTIVES To assess the impact of low flow with and without preserved left ventricular ejection fraction (LVEF) on outcomes after transcatheter aortic valve replacement (TAVR). BACKGROUND Prior studies have shown that patients with low flow, AVG, and LVEF have worse outcomes after TAVR. It is unclear whether low AVG and LVEF remain prognostic after adjusting for flow, and how the outcomes of patients with low flow with and without preserved LVEF compare after TAVR. The goal of this study was to provide insight into these open questions. METHODS Data from 340 TAVR patients at Brigham and Women's Hospital from 2011 through 2015 were analyzed. Low flow was defined as stroke volume index (SVI) ≤35 mL/m2 , low AVG as mean gradient