Balloon rupture during transcatheter aortic valve replacement.

A distinctive complication with balloon-expandable (BE) THV platforms such as the Edwards Sapien (Edwards Lifescience) is the possibility of balloon rupture during THV deployment. Balloon rupture is a rare occurrence that can result in stroke due to fragment embolism, incomplete THV expansion, and/or vascular injury upon retrieval of the balloon. Careful evaluation of preoperative computed tomography is essential to identify high-risk cases. While annular and left ventricular outflow tract (LVOT) calcification are widely acknowledged as common risks for balloon injury, it's essential to note that balloon injury can manifest at various anatomical sites. In this review, we discuss the mechanism behind balloon rupture, methods to identify cases at a heightened risk of balloon injury, approaches to mitigate the risk of rupture, and percutaneous retrieval strategies.

Snare technique to facilitate 'tall-in-short' redo-TAVR.

An 82-year-old man with a prior history of transcatheter aortic valve replacement (TAVR) with a 23-mm balloon-expandable transcatheter heart valve (THV) presented with bioprosthetic stenosis.

Fusion Imaging Guidance for Coronary Reaccess After Valve-in-Valve Transcatheter Aortic Valve Replacement.

Coronary reaccess can be difficult after valve-in-valve transcatheter aortic valve replacement. We present a case whereby prior valve-in-valve transcatheter aortic valve replacement created difficulty with coronary reaccess. Computed tomography-fluoroscopy fusion imaging was used for guidance to successfully engage the coronary arteries and perform percutaneous coronary intervention.

Implementing Formal Mitral Heart Team Improves Multidisciplinary Evaluation Rate and Survival of Patients With Severe Primary Mitral Regurgitation.

BACKGROUND: Multidisciplinary heart team (HT) evaluation is recommended for patients with severe primary mitral regurgitation to optimize treatment decisions. However, its impact on patient outcomes remains unknown. We evaluated the impact of implementing mitral HT on patient survival. METHODS AND RESULTS: We conducted a retrospective cohort study of patients with new diagnoses of severe primary mitral regurgitation in a large healthcare network echocardiogram database between 2016 and 2020. We compared the incidence of multidisciplinary evaluation by structural cardiology and cardiac surgery services and 2-year survival before and after mitral HT implementation. The 1:1 propensity-score matching between pre- and post-mitral HT used Society of Thoracic Surgeons Predicted Risk of Mortality for mitral repair, age, sex, race, heart failure symptoms, inpatient setting, history of MI, and dementia as covariates. Logistic regression identified variables associated with the likelihood of undergoing multidisciplinary evaluation. Among 70 510 echocardiograms performed, 391 patients had severe primary mitral regurgitation (median age, 77 years; 46% women). Multidisciplinary evaluation increased from 29% to 89% (P<0.001), and intervention increased from 24% to 75% following mitral HT implementation (P<0.001). Among 180 propensity-score matched patients, mortality was lower post-mitral HT at 2 years (19% versus 32%, P=0.04). The multivariable model showed that mitral HT implementation and heart failure symptoms were associated with higher odds of undergoing multidisciplinary evaluation (OR [odds ratio], 18.7 and 2.72, respectively), whereas female sex and older age were associated with lower odds (OR, 0.39 and 0.93, respectively). CONCLUSIONS: Implementation of mitral HT was associated with drastic improvement in multidisciplinary evaluation for patients with severe primary mitral regurgitation. This coincided with higher proportions of patients undergoing mechanical correction of MR and improved overall patient survival.

Impact of sex on Transcatheter aortic valve replacement outcomes: Results of a single-center study.

BACKGROUND: Early studies on transcatheter aortic valve replacement (TAVR) outcomes showed that female sex was associated with better survival. With increased use of new-generation valves, the impact of sex on contemporary TAVR outcomes is less well known. METHODS: Retrospective analysis using institutional National Cardiovascular Data Registry STS/ACC TVT data was performed on all patients undergoing TAVR at Yale New Haven Hospital from July 2012 to August 2019. New-generation valves were Evolut PRO, Evolut R, and SAPIEN 3. Old-generation valves were CoreValve, SAPIEN, and SAPIEN XT. Log-rank test and Kaplan-Meier curves were used to compare sex differences in survival up to 1 year after TAVR. Cox modeling was used to adjust for baseline and procedural characteristic differences. RESULTS: 927 consecutive patients (41.4% women) underwent TAVR. Women were older (82.8 vs 80.6 years old; p < 0.001) with higher STS mortality scores compared with men (7.6% vs 6.4%; p < 0.001) despite lower prevalence of cardiovascular comorbidities including coronary artery disease, peripheral artery disease, and smoking. Most cases used transfemoral access (90.5%) and new-generation devices (72.3%). Women received smaller valves compared with men (20-26 mm: 78.0% vs 32.9%; 29-34 mm: 22.1% vs 67.1%; overall p < 0.0001). There were no statistically significant differences between sexes in both unadjusted and adjusted 1-year mortality. CONCLUSION: Our data show no significant difference in 1-year survival between sexes using primarily new generation valves. Further studies should reassess the impact of sex on TAVR outcomes and whether newer technologies like new valve design and sizes, and CT imaging may have eliminated sex-based disparities.

Impact of Paravalvular Leak on Outcomes After Transcatheter Aortic Valve Implantation: Meta-Analysis of Kaplan-Meier-derived Individual Patient Data.

Background: Paravalvular leak (PVL) after transcatheter aortic valve implantation (TAVI) is frequent and the impact of mild PVL on outcomes remains uncertain. Our study aimed to evaluate the impact of PVL on TAVI outcomes. Methods: To analyze late outcomes of patients after TAVI according to the presence and severity of PVL, PubMed/MEDLINE, EMBASE and Google Scholar were searched for studies that reported rates of all-cause mortality/survival and/or rehospitalization and/or cardiovascular mortality accompanied by at least one Kaplan-Meier curve for any of these outcomes. We adopted a 2-stage approach to reconstruct individual patient data based on the published Kaplan-Meier graphs. Results: Thirty-eight studies with Kaplan-Meier curves met our eligibility criteria including over 25,000 patients. Patients with any degree of PVL after TAVI had a significantly higher risk of overall mortality (hazard ratio (HR), 1.52; 95% confidence interval (CI), 1.43-1.61; p < 0.001), rehospitalization (HR, 1.81; 95% CI, 1.54-2.12; p < 0.001), and cardiovascular mortality (HR, 1.52; 95% CI, 1.33-1.75; p < 0.001) over time. These findings remained consistent when we stratified the results for the methods of assessment of PVL (i.e., echocardiography vs. angiography) and PVL severity. Both moderate/severe PVL and mild PVL were associated with increased risk of overall mortality (p < 0.001), rehospitalization (p < 0.001), and cardiovascular mortality (p < 0.001) during follow-up. Conclusions: Patients with PVL, even if mild, experience higher risk of all-cause mortality, rehospitalization, and cardiovascular mortality following TAVI. These findings provide support to the implementation of procedural strategies to prevent any degree of PVL at the time of TAVI.

Impact of New-Onset Conduction Disturbances following Transcatheter Aortic Valve Replacement on Outcomes: A Single-Center Study.

Background: Transcatheter aortic valve replacement (TAVR) is known to increase the incidence of conduction disturbances compared to surgical aortic valve replacement; however, there are limited data on the impact and duration of these conduction disturbances on longer term outcomes. Objective: To determine the differential impact of persistent versus nonpersistent new-onset conduction disturbances on TAVR-related complications and outcomes. Methods: This is a single-center retrospective analysis of 927 consecutive patients with aortic stenosis who underwent TAVR at Yale New Haven Hospital from July 2012 to August 2019. Patients with new-onset conduction disturbances within 7 days following TAVR were selected for this study. Persistent and nonpersistent disturbances were, respectively, defined as persisting or not persisting on all patient ECGs for up to 1.5 years after TAVR or until death. Results: Within 7 days after TAVR, conduction disturbances occurred in 42.3% (392/927) of the patients. Conduction disturbances persisted in 150 (38%) patients and did not persist in 187 (48%) patients, and 55 (14%) patients were excluded for having mixed (both persistent and nonpersistent) disturbances. Compared with nonpersistent disturbances, patients with persistent disturbances were more likely to receive a PPM within 7 days after the TAVR procedure (46.0% versus 4.3%, p < 0.001) and had a greater unadjusted 1-year cardiac-related and all-cause mortality risk (HR 2.54, p=0.044 and HR 1.90, p=0.046, respectively). Conclusion: Persistent conduction disturbances were associated with a greater cardiac and all-cause mortality rate at one year following TAVR. Future research should investigate periprocedural factors to reduce persistent conduction disturbances and outcomes beyond one year follow-up.

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

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

Risk factors and mortality associated with permanent pacemaker after surgical or transcatheter aortic valve replacement: Early versus late implantation.

INTRODUCTION: Inflation of transcatheter aortic valve replacement (TAVR) procedures compared to surgical aortic valve replacement (SAVR) has increased the number of patients requiring a postprocedure permanent pacemaker (PPM). We investigate the impact of PPM on mid-term mortality comparing SAVR versus TAVR procedures and risk factors for early and late (>14 days) need of PPM. METHODS: We conducted a retrospective, single-center evaluation of 903 patients that underwent either SAVR or TAVR procedures at the Yale New Haven Hospital from 2012 to 2017. Patients were stratified into PPM and non-PPM groups. We performed Kaplan-Meier and Cox proportional hazard analysis to characterize mid-term mortality. Further subgroup analysis was performed to identify risk factors for early and late PPM implantation in the TAVR cohort. RESULTS: There was no correlation between PPM implantation and mid-term mortality in both SAVR (hazard ratio [HR] = 0.69; confidence interval [CI] = 0.21-2.30; p = .56) and TAVR (HR = 0.70; CI = 0.42-1.17; p = .18) patients. The presence of the right bundle branch block (Odds ratio = 24.07; 95% CI = 2.34-247.64, p = .007) was associated with higher odds of early PPM requirement after TAVR procedures. CONCLUSION: PPM placement after SAVR or TAVR procedures is not associated with increased mid-term mortality. In-depth characterization of risk factors for early and late PPM implantation will require further analysis in the growing TAVR patient population.

Trends in utilization, outcomes, and readmissions after transcatheter mitral valve replacement.

BACKGROUND: There is a paucity of real-world data regarding the temporal trends and outcomes of trans-septal transcatheter mitral valve replacement (TS-TMVR) in the United States (US). METHODS: We queried the Nationwide Readmissions Database (October 2015 to December 2018) for patients undergoing TS-TMVR procedures. We reported the temporal trends in the utilization, in-hospital outcomes and 30-day readmissions after TS-TMVR. The main study outcome was in-hospital mortality. RESULTS: There was an increase in the number of TS-TMVR procedures over time (48 in 2015 vs. 978 in 2018, Ptrend < 0.001), with a notable increase in the proportion of women (Ptrend  = 0.04) and the prevalence of diabetes (Ptrend  = 0.03). There was an increase in the number of centers performing TS-TMVR (21 in 2015 vs. 164 in 2018, Ptrend < 0.001). The overall in-hospital mortality was 7.2% with no change over time (6.3% in 2015 vs. to 5.2% in 2018, Ptrend  = 0.67). There was no change in the frequency of in-hospital complications after TS-TMVR; however, the median length of stay has decreased over time. The overall 30-day readmission rate was 17.8%, with no change during the study years. The most frequent cause for 30-day readmission after TS-TMVR was acute heart failure followed by bleeding and infection-related complications. Prior coagulopathy and small-sized hospitals were independently associated with higher in-hospital mortality and 30-day readmissions. CONCLUSION: This nationwide observational analysis of real-world data showed an increase in the number of TS-TMVR procedures over time, which is now performed at a greater number of centers. There was no change in the rate of in-hospital mortality, complications or 30-day readmissions; but a significant reduction in the length of hospital stay over time was noted. As the number of TS-TMVR continue to expand, these data provide a perspective on the early experience with this procedure.

Impact of post-procedural length of stay on short-term outcomes and readmissions after TAVR and MitraClip.

Background: Post-procedural hospital length of stay (P-LOS) is an important determinant of cost-related outcomes. In the present study, we aimed to assess the impact of P-LOS on short-term outcomes after transcatheter aortic valve replacement (TAVR) and MitraClip. Methods: We performed a retrospective cohort study, retrieving data from the National Readmissions Database (NRD) for patients who underwent transfemoral TAVR and MitraClip between January 2014 and December 2017. We employed multivariable logistic regression to evaluate the association between P-LOS and 30-day all-cause mortality and readmissions. Results: A total of 65,726 and 7347 patients underwent TAVR and MitraClip, respectively within the study period. After 30 days of discharge, 13.7% and 15.1% of TAVR and MitraClip patients were readmitted for any reason, while 0.5% and 0.9% died within the readmission hospitalization. A longer P-LOS was associated with an increased risk of 30-day all-cause readmission in both TAVR (OR = 1.027, 95% CI [1.023-1.032]) and MitraClip (OR = 1.025, 95%CI [1.012-1.038]) patients. This finding remained true for patients who developed or did not develop complications after both procedures. In terms of 30-day inhospital mortality, a longer P-LOS was associated with a higher risk in TAVR patients (OR = 1.039, 95%CI [1.028-1.049]), but no increased risk in MitraClip patients (OR = 1.014, 95%CI [0.985-1.044]). Other predictors of 30-day readmission after both procedures included heart failure, post-procedural acute kidney injury, and discharge with disability. Conclusion: The current study shows that shorter P-LOS was associated with reduced risk of short-term readmission after both TAVR and MitraClip and reduced short-term mortality after TAVR (mainly in patients who developed post-procedural complications). Shorter P-LOS is a predictor of readmission and sicker patient group. Patients requiring longer LOS should be followed closely to prevent readmission and enhance better outcomes. Future studies evaluating P-LOS impact on long-term and patient-oriented outcomes are needed.

First Transfemoral Implantation of a Novel Transcatheter Valve in an LVAD Patient With Aortic Insufficiency.

An 80-year-old man with a destination left ventricular assist device (LVAD) presented with decompensated heart failure. Evaluation demonstrated numerous LVAD high power spike events, significant aortic regurgitation, and hemolysis. He underwent successful aortic valve replacement with a novel transcatheter valve and LVAD pump exchange that resulted in an improvement in his clinical status. (Level of Difficulty: Advanced.).

Current state of transcatheter mitral valve implantation in bioprosthetic mitral valve and in mitral ring as a treatment approach for failed mitral prosthesis.

With heightened awareness of mitral valve disease and improvement in surgical techniques, the use of mitral valve bioprostheses has increased. There is a large aging population with prior surgical valvular interventions. Limited durability of the prosthesis due to valvular degeneration over time may necessitate the need for repair or replacement of the prior prosthesis in the future. This usually entails another surgical intervention in this population with elevated risk for a reoperation. There is an ongoing clinical need for newer, less invasive options that are feasible and carry a lower complication rate. The advent of transcatheter heart valve (THV) therapies has opened up a wide range of therapeutic options for treatment of a failed bioprosthesis. Their safety and feasibility are now well established. This article serves as a review of the currently available THVs for implantation in the mitral position, the pre-procedural assessment, the challenges associated with implantation, as well as outcomes associated with a mitral valve-in-valve (VIV) and a mitral valve-in-ring (VIR) procedure.

Alternate accesses for transcatheter aortic valve replacement: A network meta-analysis.

BACKGROUND: When transfemoral (TF) access is contraindicated in patients undergoing transcatheter aortic valve replacement (TAVR), alternate access strategies are considered. The choice of one alternate access over the other remains controversial. METHODS: Following a comprehensive literature search, studies comparing any combination of TF, transapical (TA), transaortic (TAo), transcarotid (TC), and trans-subclavian (TS) TAVR were identified. Data were pooled using fixed- and random-effects network meta-analysis. Rank scores with probability ranks of different treatment groups were calculated. RESULTS: Eighty-four studies (26,449 patients) were included. Compared to TF access, TA and TAo accesses were associated with higher 30-day mortality (odds ratio [OR] 1.60, 95% confidence interval [CI] 1.31-1.94; OR 1.79, 95% CI 1.21-2.66, respectively), while the TC and TS showed no difference (OR 1.12, 95% CI 0.64-1.95; OR 1.23, 95% CI 0.67-2.27, respectively); TF access ranked best followed by TC. There was no significant difference in 30-day stroke; TC access ranked best followed by TS. At a weighted mean follow-up of 1.6 years, TA and TAo accesses were associated with higher long-term mortality versus TF (incidence rate ratio [IRR] 1.31, 95% CI 1.18-1.45; IRR 1.41, 95% CI 1.11-1.79, respectively); there was no difference between TC and TS versus TF access (IRR 1.02, 95% CI 0.70-1.47; IRR 1.16, 95% CI 0.82-1.66, respectively); TF access ranked best followed by TC. At a weighted mean follow-up of 1.4 years, only TA access was associated with higher long-term stroke compared to TF (IRR 3.01, 95% CI 1.15-7.87); TF access ranked as the best strategy followed by TAo. CONCLUSION: TC and TS approaches are associated with superior postoperative outcomes compared to other TAVR alternate access strategies. Randomized trials definitively assessing the safety and efficacy of alternate access strategies are needed.

Comparison of Transcatheter and Open Mitral Valve Repair Among Patients With Mitral Regurgitation.

In 2013, the Food and Drug Administration approved the first transcatheter mitral valve repair (TMVr) device for degenerative mitral regurgitation for patients at prohibitive surgical risk. To better understand contemporary utilization trends and outcomes, we reviewed hospitalizations, identified using International Classification of Diseases, Ninth Revision and International Classification of Diseases, Tenth Revision codes, in which the patient underwent TMVr or mitral valve repair (MVr) with a diagnosis of mitral regurgitation, without stenosis, from the National (Nationwide) Inpatient Sample from 2014 to 2017. We included 10,020 hospitalizations in which the patient underwent TMVr and 5845 in which the patient underwent MVr and assessed trends in demographic characteristics, patient comorbidities, total hospital charges, and outcomes. Transcatheter mitral valve repair experienced exponential growth, increasing from 150 to 5115 over the study period (P<.001 for trend), whereas MVr grew to a lesser degree. The median length of stay for TMVr decreased from 4 to 2 days; mortality declined from 3.3% to 1.6% (P<.001 for both). Both TMVr and MVr rates of discharge home increased over the study period. Total charges for TMVr increased from $149,582 to $178,109, whereas those for MVr increased to a lesser degree, from $149,426 to $157,146 (P<.001 for both). Discharge disposition, length of stay, and in-hospital mortality all exhibited favorable trends for both procedures. Caution must be exercised in direct comparisons between procedures as they target somewhat different populations. With expanded indications for TMVr, we anticipate further increases in procedural volume, although the effect on MVr remains unclear.

Tricuspid clip implantation using the MitraClip system-A step-by-step guide.

Many novel percutaneous interventions are being developed for application in the tricuspid valve position. At the present time, there are no commercially available devices for this application. There has been mounting evidence supporting the safety and efficacy of using the MitraClip system on the tricuspid valve. This review summarizes the peer reviewed data available to date supporting this procedure, outlines the step-by-step maneuvers using the MitraClip system for this application, and imaging techniques used prior to and during the procedure.

Outcomes of transcatheter tricuspid valve intervention by right ventricular function: a multicentre propensity-matched analysis.

BACKGROUND: Tricuspid regurgitation (TR) has a poor prognosis and limited treatment options and is frequently accompanied by right ventricular (RV) dysfunction. Transcatheter tricuspid valve interventions (TTVI) to reduce TR have been shown to be safe and feasible with encouraging early results. Patient selection for TTVI remains challenging, with the role of right ventricular (RV) function being unknown. AIMS: The aims of this study were 1) to investigate survival in a TTVI-treated patient population and a conservatively treated TR population, and 2) to evaluate the outcome of TTVI as compared to conservative treatment stratified according to the degree of RV function. METHODS: We studied 684 patients from the multicentre TriValve cohort (TTVI cohort) and compared them to 914 conservatively treated patients from two tertiary care centres. Propensity matching identified 213 pairs of patients with severe TR. As we observed a non-linear relationship of RV function and TTVI outcome, we stratified patients according to tricuspid annular plane systolic excursion (TAPSE) to preserved (TAPSE >17 mm), mid-range (TAPSE 13-17 mm) and reduced (TAPSE <13 mm) RV function. The primary outcome was one-year all-cause mortality. RESULTS: TTVI was associated with a survival benefit in patients with severe TR when compared to matched controls (one-year mortality rate: 13.1% vs 25.8%; p=0.031). Of the three RV subgroups, only in patients with mid-range RV function was TTVI associated with an improved survival (p log-rank 0.004). In these patients, procedural success was associated with a reduced hazard ratio for all-cause mortality (HR 0.22; 95% CI: 0.09, 0.57). CONCLUSIONS: TTVI is associated with reduced mortality compared to conservative therapy and might exert its highest treatment effect in patients with mid-range reduced RV function.