Transcatheter tricuspid valve intervention in the presence of a cardiac implantable electronic device; state of the art review.

A large proportion of patients referred for transcatheter tricuspid valve intervention (TTVI) will have the presence of a cardiac implantable electronic device (CIED). In such patients, surgical correction of tricuspid regurgitation (TR) is associated with high rates of morbidity and mortality. Transvenous lead extraction (TLE) could potentially ameliorate CIED-induced TR; however, it carries inherent risks and frequently does not result in TR improvement. As multiple TTVI devices are in trial to gain regulatory approval, understanding which therapy is most appropriate among patients with a CIED is essential. This review centers on the nonsurgical treatment, including TLE and transcatheter tricuspid valve repair and replacement options, aimed at enhancing outcomes in patients with TR who also have concurrent CIEDs.

Multiple Valvular Heart Disease in the Transcatheter Era: A State-of-the-Art Review.

Although existing guidelines offer strong recommendations for single valvular dysfunction, the growing prevalence of multiple valvular heart disease (MVHD) in our aging population is challenging the clarity of clinical guidance. Traditional diagnostic modalities, such as echocardiography, face inherent constraints in precisely quantifying valvular dysfunction due to the hemodynamic interactions that occur with multiple valve involvement. Therefore, many patients with MVHD present at a later stage in their disease course and with an elevated surgical risk. The expansion of transcatheter therapy for the treatment of valvular heart disease has added new opportunities for higher-risk patients. However, the impact of isolated valve therapies on patients with MVHD is still not well understood. This review focuses on the etiology, diagnostic challenges, and therapeutic considerations for some of the most common concomitant valvular abnormalities that occur in our daily clinic population.

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.

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.

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.

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.

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.

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.

Corticosteroid Therapy and Vascular Complications in Patients Undergoing Transcatheter Aortic Valve Replacement: A Meta-analysis With Meta-regression.

Background: Corticosteroid use is associated with vascular fragility, prolonged wound healing, and infections. Therefore, we sought to compare outcomes between patients with aortic stenosis undergoing transcatheter aortic valve replacement who were using corticosteroids versus those who were not. Methods: This is a study-level meta-analysis and meta-regression of observational studies. The primary end points of this study were rates of vascular complication (both major and minor), life-threatening bleeding, and 30-day mortality. Secondary end points included acute kidney injury rates, annular rupture, cardiac tamponade, closure device failure, coronary obstruction, periprocedural myocardial infarction, permanent pacemaker implantation, stroke, and specific vascular complications with its complementary therapy. Results: Across the studies, patients were slightly predominantly female, older, and had a mean left ventricular ejection fraction of more than 50% with an intermediate Logistic EuroScore II. Significant differences were observed in the vascular complication rates between patients on corticosteroids and those who were corticosteroid-free (relative risk, 0.63; 95% CI, 0.35-0.90; P <.001), driven primarily by arterial occlusion, surgery, balloon angioplasty, and stenting (relative risk, 0.63; 95% CI, 0.32-0.93; P <.05). There was no difference in the 30-day mortality. No differences were seen in the length of corticosteroid therapies. For the secondary outcomes, there was an increased risk of annular rupture and cardiac tamponade in patients taking corticosteroids. Conclusions: In conclusion, this is the first meta-analysis with meta-regression that showed a higher risk for vascular complications and life-threatening bleeding in patients on corticosteroid therapy undergoing transcatheter aortic valve replacement, despite no increase in the risk of 30-day mortality.

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.