Transcatheter heart valve explant with infective endocarditis-associated prosthesis failure and outcomes: the EXPLANT-TAVR international registry.

BACKGROUND AND AIMS: Surgical explantation of transcatheter heart valves (THVs) is rapidly increasing, but there are limited data on patients with THV-associated infective endocarditis (IE). This study aims to assess the outcomes of patients undergoing THV explant for IE. METHODS: All patients who underwent THV explant between 2011 and 2022 from 44 sites in the EXPLANT-TAVR registry were identified. Patients with IE as the reason for THV explant were compared to those with other mechanisms of bioprosthetic valve dysfunction (BVD). RESULTS: A total of 372 patients from the EXPLANT-TAVR registry were included. Among them, 184 (49.5%) patients underwent THV explant due to IE and 188 (50.5%) patients due to BVD. At the index transcatheter aortic valve replacement, patients undergoing THV explant for IE were older (74.3 ± 8.6 vs. 71 ± 10.6 years) and had a lower Society of Thoracic Surgeons risk score [2.6% (1.8-5.0) vs. 3.3% (2.1-5.6), P = .029] compared to patients with BVD. Compared to BVD, IE patients had longer intensive care unit and hospital stays (P < .05) and higher stroke rates at 30 days (8.6% vs. 2.9%, P = .032) and 1 year (16.2% vs. 5.2%, P = .010). Adjusted in-hospital, 30-day, and 1-year mortality was 12.1%, 16.1%, and 33.8%, respectively, for the entire cohort, with no significant differences between groups. Although mortality was numerically higher in IE patients 3 years postsurgery (29.6% for BVD vs. 43.9% for IE), Kaplan-Meier analysis showed no significant differences between groups (P = .16). CONCLUSIONS: In the EXPLANT-TAVR registry, patients undergoing THV explant for IE had higher 30-day and 1-year stroke rates and longer intensive care unit and hospital stays. Moreover, patients undergoing THV explant for IE had a higher 3-year mortality rate, which did not reach statistical significance given the relatively small sample size of this unique cohort and the reduced number of events.

Infection of Transcatheter Valvular Devices.

PURPOSE OF REVIEW: This review explores the epidemiology, clinical traits, and diagnosis of Transcatheter Aortic Valve Replacement-Associated Infective Endocarditis (TAVR-IE) and mitral transcatheter edge-to-edge repair infective endocarditis (TEER-IE), focusing on a multimodal imaging approach. It addresses the rising prevalence of TAVR and TEER, emphasizing the need to understand long-term complications and clinical consequences, which poses significant challenges despite advancements in valve technology. RECENT FINDINGS: Studies report a variable incidence of TAVR-IE and TEER-IE influenced by diverse patient risk profiles and procedural factors. Younger age, male gender, and certain comorbidities emerge as patient-related risk factors. Procedure-related factors include intervention location, valve type, and technical aspects. Microbiologically, Staphylococcus aureus, Viridans Group Streptococcus, and Enterococcus are frequently encountered pathogens. TAVR-IE and TEER-IE diagnosis involves a multimodal imaging approach due to limitations in echocardiography. Blood cultures and imaging aid identification, with Fluorescence in situ hybridization is showing promise. Treatment encompasses medical management with antibiotics and, when necessary, surgical intervention. The management approach requires a multidisciplinary "Endocarditis Team." This review underscores the need for continued research to refine risk prediction, enhance diagnostic accuracy, and optimize management strategies for TAVR-IE, considering the evolving landscape of transcatheter interventions.

Ultrasound-Assisted Versus Standard Catheter-Directed Thrombolysis for Acute Pulmonary Embolism: Insights From National Inpatient Sample.

Background: Pulmonary embolism is one of the leading causes of morbidity and mortality in the United States. Catheter-directed therapies have emerged as a promising treatment for managing intermediate- and high-risk patients; however, data comparing standard catheter-directed thrombolysis (SCDT) and ultrasound-assisted thrombolysis (USAT) are limited. This study aimed to investigate trends, outcomes, and predictors of mortality of both modalities from a nationally representative sample. Methods: This analysis used data from the National Inpatient Sample years 2016-2020. The primary outcome was in-hospital mortality. A multivariable regression model was used to compare the outcomes. Results: Among 39,430 patients who received catheter-directed thrombolysis, 26,710 (76.8%) received SCDT and 8060 (23.2%) received USAT. The utilization of SCDT and USAT increased during the study years except for 2020. In-hospital mortality was lower among patients who received USAT (2.7% vs 3.8%; P = .04) compared with patients who received SCDT in the unadjusted analysis. On multivariable regression analysis, there was no difference in the incidence of in-hospital mortality between USAT and SCDT (odds ratio, 0.75; 95% CI, 0.52-1.08; P = .13). There were no significant differences between SCDT and USAT groups in the rate of bleeding adverse events including intracranial hemorrhage (0.6% vs 0.4%; P = .47), and nonintracranial major bleeding (4.2% vs 4.1%; P = .72). Conclusions: Ultrasound-assisted thrombolysis was associated with similar in-hospital mortality and bleeding complications compared with SCDT for acute pulmonary embolism. Further studies are warranted to confirm evaluate the long-term outcomes with both modalities.

Echocardiographic Profiling Predicts Clinical Outcomes After Mitral Transcatheter Edge-to-Edge Repair.

BACKGROUND: Prior studies investigating the impact of residual mitral regurgitation (MR), tricuspid regurgitation (TR), and elevated predischarge transmitral mean pressure gradient (TMPG) on outcomes after mitral transcatheter edge-to-edge repair (TEER) have assessed each parameter in isolation. We sought to examine the prognostic value of combining predischarge MR, TR, and TMPG to study long-term outcomes after TEER. METHODS AND RESULTS: We reviewed the records of 291 patients who underwent successful mitral TEER at our institution between March 2014 and June 2022. Using well-established outcomes-related cutoffs for predischarge MR (≥moderate), TR (≥moderate), and TMPG (≥5 mm Hg), 3 echo profiles were developed based on the number of risk factors present (optimal: 0 risk factors, mixed: 1 risk factor, poor: ≥2 risk factors). Discrimination of the profiles for predicting the primary composite end point of all-cause mortality and heart failure hospitalization at 2 years was examined using Cox regression. Overall, mean age was 76.7±10.6 years, 43.3% were women, and 53% had primary MR. Two-year event-free survival was 61%. Predischarge TR≥moderate, MR≥moderate, and TMPG≥5 mm Hg were risk factors associated with the primary end point. Compared with the optimal profile, there was an incremental risk in 2-year event-rate with each worsening profile (optimal as reference; mixed profile: hazard ratio (HR), 2.87 [95% CI, 1.71-5.17], P<0.001; poor profile: HR, 3.76 [95% CI, 1.84-6.53], P<0.001). Echocardiographic profile was statistically associated with the 2-year mortality end point (optimal as reference; mixed profile: HR, 3.55 [95% CI, 1.81-5.96], P<0.001; poor profile: HR, 3.39 [95% CI, 2.56-7.33], P=0.02). CONCLUSIONS: The echocardiographic profile integrating predischarge TR, MR, and TMPG presents a novel prognostic stratification tool for patients undergoing mitral TEER.

Feasibility and Safety of Intracardiac Echocardiography Guidance in Mitral Transcatheter Edge-to-Edge Repair: Analysis of the National Inpatient Sample Data From 2015 to 2020.

Data on the use of intracardiac echocardiography (ICE) guidance in mitral transcatheter edge-to-edge repair (mTEER) procedure is limited to case reports and small case series. Our study aims to assess the feasibility, safety, utilization patterns, and clinical outcomes of mTEER procedure with ICE guidance using a nationally representative real-world cohort of patients. This study used the National Inpatient Sample database from quarter 4 of 2015 to 2020. We used a propensity-matched analysis and adjusted odds ratios for in-hospital outcomes/complications. A P value of < 0.05 was considered significant. A total of 38,770 weighted cases of mTEER were identified. Of the included patients 665 patients underwent ICE-guided mTEER while 38,105 had TEE-guided mTEER. There were no differences in the in-hospital mortality between both groups (2.5% vs 3.0%, P = 0.58). Adjusted odds of in-hospital mortality (aOR 0.83, 95%CI [0.42-1.64]) were not significantly different. There were no differences in periprocedural complications including cardiac (aOR 0.85, 95%CI [0.54-1.35]), bleeding (aOR 1.45, 95%CI [0.93-2.33]), respiratory (aOR 0.88, 95%CI [0.61-1.25]), and renal (aOR 0.89, 95%CI [0.66-1.20]) complications between patients undergoing ICE-guided vs TEE-guided mTEER. There was no difference in GI complications between both groups (aOR 1.11, 95%CI [0.46-2.70]). The adjusted length of stay was less among ICE-guided mTEER (median: 1 vs 2, P < 0.01) with lower inflation-adjusted costs of hospitalization ($35,513 vs $47,067, P < 0.01). ICE-guided mTEER is safe when compared with TEE guided mTEER with no significant differences in in-hospital mortality, cardiac, bleeding, respiratory, and renal complications.

Myocardial Blood Flow Reserve, Microvascular Coronary Health, and Myocardial Remodeling in Patients With Aortic Stenosis.

BACKGROUND: Coronary microvascular function and hemodynamics may play a role in coronary circulation and myocardial remodeling in patients with aortic stenosis (AS). We aimed to evaluate the relationship between myocardial blood flow and myocardial function in patients with AS, no AS, and aortic valve sclerosis. METHODS AND RESULTS: We included consecutive patients who had resting transthoracic echocardiography and clinically indicated positron emission tomography myocardial perfusion imaging to capture their left ventricular ejection fraction, global longitudinal strain (GLS), and myocardial flow reserve (MFR). The primary outcome was major adverse cardiovascular event (all-cause mortality, myocardial infarction, or late revascularization). There were 2778 patients (208 with aortic sclerosis, 39 with prosthetic aortic valve, 2406 with no AS, and 54, 49, and 22 with mild, moderate, and severe AS, respectively). Increasing AS severity was associated with impaired MFR (P<0.001) and GLS (P<0.001), even when perfusion was normal. Statistically significant associations were noted between MFR and GLS, MFR and left ventricular ejection fraction, and MFR and left ventricular ejection fraction reserve. After a median follow-up of 349 (interquartile range, 116-662) days, 4 (7.4%), 5 (10.2%), and 6 (27.3%) patients experienced a major adverse cardiovascular event in the mild, moderate, and severe AS groups, respectively. In a matched-control analysis, patients with mild-to-moderate AS had higher rates of impaired MFR (52.9% versus 39.9%; P=0.048) and major adverse cardiovascular event (11.8% versus 3.0%; P=0.002). CONCLUSIONS: Despite lack of ischemia, as severity of AS increased, MFR decreased and GLS worsened, reflecting worse coronary microvascular health and myocardial remodeling. Positron emission tomography-derived MFR showed a significant independent correlation with left ventricular ejection fraction and GLS. Patients with prosthetic aortic valve showed a high prevalence of impaired MFR.

Percutaneous coronary intervention before transcatheter aortic valve implantation: A propensity score matched analysis.

BACKGROUND: The role of percutaneous coronary intervention (PCI) in patients with stable coronary artery disease (CAD) who subsequently undergo transcatheter aortic valve replacement (TAVR) remains uncertain. Therefore, we conducted this study to assess the association of PCI before TAVR with mortality and cardiovascular outcomes. METHODS: We used the TriNetX database (Jan 2012 - Aug 2022) and grouped patients into PCI (3 months or less) before TAVR and no PCI. We performed propensity score matched (PSM) analyses for outcomes at 30 days and 1 year. RESULTS: Of 17,120 patients undergoing TAVR, 2322 (14 %) had PCI, and 14,798 (86 %) did not have PCI before TAVR. In the PSM cohort (2026 patients in each group), PCI was not associated with lower all-cause mortality at 30 days (HR: 1.25, 95 % CI: 0.82-1.90) or 1 year (HR: 1.02, 95 % CI: 0.83-1.24). Frequency of repeat PCI after TAVR was low in both no PCI vs. PCI (2.4 % vs. 1.2 %) at 1 year; PCI was associated with a lower rate of repeat PCI (HR: 0.49, 95 % CI: 0.30-0.80). Sensitivity analysis revealed an E-value of 3.5 for repeat PCI (E-value for lower CI for HR: 1.81). PCI was not linked to reductions in MI, heart failure exacerbation, all-cause hospitalization, major bleeding, or permanent pacemaker/implantable cardioverter defibrillator. CONCLUSION: This analysis showed that PCI prior to TAVR was not associated with improvement in all-cause mortality. However, PCI was associated with a reduced rate of repeat PCI at 1 year.

Association of Secondary Mitral Regurgitation and Right Ventricular Dysfunction among Patients with Non-Ischemic Cardiomyopathy.

AIMS: The association between secondary mitral regurgitation (MR) and right ventricular (RV) dysfunction in heart failure patients with non-ischemic cardiomyopathy (NICM) is unclear. Hence, our objective was to study the association between secondary MR and the occurrence of RV dysfunction among patients with NICM using cardiac magnetic resonance (CMR). METHODS AND RESULTS: Patients with NICM were enrolled in a prospective observational registry between 2008-2019. CMR was used to quantify MR severity along with RV function. RV dysfunction was defined as RV ejection fraction <45%. The outcome of the study was a composite event of all-cause death, heart transplantation, or left ventricular assist device implantation at follow-up. In the study cohort of 241 patients, RV dysfunction (RVEF < 45%) was present in 148 (61%). In comparison to patients without RV dysfunction, those with RV dysfunction had higher median MR volume (23 ml [IQR 16-31ml] vs 18 ml [IQR 12-25 ml], P=0.002) and MR fraction (33% [IQR 25-43%] vs 22% [IQR 15-29%], P<0.001). Furthermore, secondary MR was independently associated with RV dysfunction: MR volume ≥ 24ml (OR 3.21, 95% CI 1.26-8.15, P= 0.01) and MR fraction≥ 30% (OR 5.46, 95% 2.23-13.35, P=0.002). Increasing RVEF (every 1% increase) was independently associated with lower risk of adverse events (HR 0.98, 95% 0.95, 1.00, P=0.047). CONCLUSIONS: In patients with NICM, the severity of secondary MR is associated with an increased prevalence of RV dysfunction. RV dysfunction is not only associated with the severity of LV dysfunction, but also with the severity of secondary MR.

Impact of Left Atrial Pressure on Outcomes After Mitral Transcatheter Edge-to-Edge Repair.

Background: Increased left atrial pressure (LAP) has been associated with adverse outcomes after mitral transcatheter edge-to-edge repair (M-TEER). We sought to evaluate outcomes based on differences in post-procedural LAP measured after final clip deployment. Methods: We included consecutive patients who underwent M-TEER at our institution between 2014-2022 with LAP monitoring. Patients were stratified into 3 groups according to tertiles of post-TEER mean LAP. Outcomes were assessed using Kaplan-Meier analysis and Cox proportional hazard models. Results: We included 273 patients (mean age 76.8±10.8 years, 42.5% women, 78.4% Caucasian). The mean post-TEER LAP was 8.7±1.7 mmHg in tertile 1 (N=85), 14.4±1.6 mmHg in tertile 2 (N=95), and 21.9±3.8 mmHg in tertile 3 (N=93). In comparison with tertile 1, both tertiles 2 and 3 were associated with increased risk of all-cause mortality or heart failure hospitalization at 2 years (adjHR 2.27, 95% CI 1.25-4.12; and adjHR 3.00, 95% CI 1.59-5.64 respectively). Among patients with primary MR, higher LAP was associated with increased risk of 2-year all-cause mortality or heart failure hospitalization [tertile 2 vs. 1: adjHR 3.00, 95% CI 1.37-6.56; and tertile 3 vs. 1: adjHR 5.52, 95% CI 2.04-14.95). However, in patients with secondary MR, neither being in tertile 2 (adjHR 1.53; 95% CI 0.55-4.24), nor tertile 3 (adjHR 2.18; 95% CI 0.82-5.77) were associated with the composite outcome compared with tertile 1. Any degree of LAP reduction following M-TEER was associated with lower mortality or heart failure hospitalization compared with no LAP reduction (adjHR 0.59; 95% CI 0.39-0.88). Conclusions: Elevated LAP after M-TEER was associated with increased 2-year risk of mortality or heart failure hospitalization. Exploration of reasons for elevated LAP after M-TEER, and ways to lower it warrant further investigation.

Prognostic Value of Right Ventricular Afterload in Patients Undergoing Mitral Transcatheter Edge-to-Edge Repair.

BACKGROUND: Pulmonary hypertension (PH) and secondary mitral regurgitation (MR) are associated with adverse outcomes after mitral transcatheter edge-to-edge repair. We aim to study the prognostic value of invasively measured right ventricular afterload in patients undergoing mitral transcatheter edge-to-edge repair. METHODS AND RESULTS: We identified patients who underwent right heart catheterization ≤1 month before transcatheter edge-to-edge repair. The end points were all-cause mortality and a composite of mortality and heart failure hospitalization at 2 years. Using the receiver operating characteristic curve-derived threshold of 0.6 for pulmonary effective arterial elastance ([Ea], pulmonary artery systolic pressure/stroke volume), patients were stratified into 3 profiles based on PH severity (low elastance [HE]: Ea <0.6/mean pulmonary artery pressure (mPAP)) <35; High Elastance with No/Mild PH (HE-): Ea ≥0.6/mPAP <35; and HE with Moderate/Severe PH (HE+): Ea ≥0.6/mPAP ≥35) and MR pathogenesis (Primary MR [PMR])/low elastance, PMR/HE, and secondary MR). The association between this classification and clinical outcomes was examined using Cox regression. Among 114 patients included, 50.9% had PMR. Mean±SD age was 74.7±10.6 years. Patients with Ea ≥0.6 were more likely to have diabetes, atrial fibrillation, New York Heart Association III/IV status, and secondary MR (all P<0.05). Overall, 2-year cumulative survival was 71.1% and was lower in patients with secondary MR and mPAP ≥35. Compared with patients with low elastance, cumulative 2-year event-free survival was significantly lower in HE- and HE+ patients (85.5% versus 50.4% versus 41.0%, respectively, P=0.001). Also, cumulative 2-year event-free survival was significantly higher in patients with PMR/low elastance when compared with PMR/HE and patients with secondary mitral regurgitation (85.5% versus 55.5% versus 46.1%, respectively, P=0.005). CONCLUSIONS: Assessment of the preprocedural cardiopulmonary profile based on mPAP, MR pathogenesis, and Ea guides patient selection by identifying hemodynamic features that indicate likely benefit from mitral-transcatheter edge-to-edge repair in PH or lack thereof.

Impact of transcatheter heart valve type on outcomes of surgical explantation after failed transcatheter aortic valve replacement: the EXPLANT-TAVR international registry.

BACKGROUND: There are limited data on the impact of transcatheter heart valve (THV) type on the outcomes of surgical explantation after THV failure. AIMS: We sought to determine the outcomes of transcatheter aortic valve replacement (TAVR) explantation for failed balloon-expandable valves (BEV) versus self-expanding valves (SEV). METHODS: From November 2009 to February 2022, 401 patients across 42 centres in the EXPLANT-TAVR registry underwent TAVR explantation during a separate admission from the initial TAVR. Mechanically expandable valves (N=10, 2.5%) were excluded. The outcomes of TAVR explantation were compared for 202 (51.7%) failed BEV and 189 (48.3%) failed SEV. RESULTS: Among 391 patients analysed (mean age: 73.0±9.8 years; 33.8% female), the median time from index TAVR to TAVR explantation was 13.3 months (interquartile range 5.1-34.8), with no differences between groups. Indications for TAVR explantation included endocarditis (36.0% failed SEV vs 55.4% failed BEV; p<0.001), paravalvular leak (21.2% vs 11.9%; p=0.014), structural valve deterioration (30.2% vs 21.8%; p=0.065) and prosthesis-patient mismatch (8.5% vs 10.4%; p=0.61). The SEV group trended fewer urgent/emergency surgeries (52.0% vs 62.3%; p=0.057) and more root replacement (15.3% vs 7.4%; p=0.016). Concomitant cardiac procedures were performed in 57.8% of patients, including coronary artery bypass graft (24.8%), and mitral (38.9%) and tricuspid (14.6%) valve surgery, with no differences between groups. In-hospital, 30-day, and 1-year mortality and stroke rates were similar between groups (allp>0.05), with no differences in cumulative mortality at 3 years (log-rank p=0.95). On multivariable analysis, concomitant mitral surgery was an independent predictor of 1-year mortality after BEV explant (hazard ratio [HR] 2.00, 95% confidence interval [CI]: 1.07-3.72) and SEV explant (HR 2.00, 95% CI: 1.08-3.69). CONCLUSIONS: In the EXPLANT-TAVR global registry, BEV and SEV groups had different indications for surgical explantation, with more root replacements in SEV failure, but no differences in midterm mortality and morbidities. Further refinement of TAVR explantation techniques are important to improving outcomes.

Mitral Valve-in-Valve Versus Repeat Surgical Mitral Valve Replacement in Patients With Failed Mitral Bioprostheses.

Background: Transcatheter mitral valve-in-valve (MViV) replacement has emerged as an alternative to redo surgical mitral valve replacement (redo-SMVR) in patients with failed mitral bioprostheses deemed to be at a high surgical risk. The aim of this analysis was to compare the outcomes of MViV replacement with those of redo-SMVR in patients with a failed bioprosthetic mitral valve. Methods: We performed a study-level meta-analysis that compared MViV replacement with redo-SMVR in patients with failed mitral bioprostheses. Seven observational studies, with a total of 5083 patients, were included (1138 patients [22.4%] in the MViV replacement arm). The primary focus was all-cause mortality. Additional outcomes included major bleeding, stroke, vascular complications, and mean mitral valve gradient at follow-up. Results: The in-hospital mortality was lower in patients who underwent MViV replacement than in those who underwent redo-SMVR (odds ratio [OR], 0.64; 95% CI, 0.53-0.78; P = .0023). The short-term mortality (<1 year) was numerically lower in the MViV replacement group (OR, 0.45; 95% CI, 0.18-1.13; P = .069). At 1 year, the risk of mortality was similar in the 2 groups (OR, 0.99; 95% CI, 0.69-1.40; P = .906), and at midterm follow-up (≥1 year), there was a numerically higher risk of mortality in the MViV replacement group (OR, 1.51; 95% CI, 1.00-2.29; P = .051). The risk of major bleeding was significantly lower in the MViV replacement group (OR, 0.23; 95% CI, 0.10-0.56; P = .01). Additionally, stroke and vascular complications were similar between the 2 groups. Conclusions: The in-hospital mortality was lower in the MViV replacement group than in the redo-SMVR group. There were no differences in mortality at short-term (<1 year), 1-year, or midterm (≥1 year) follow-ups.

Feasibility and Safety of Intracardiac Echocardiography Use in Transcatheter Left Atrial Appendage Closure Procedures.

Background: Left atrial appendage closure (LAAC) is usually performed under the guidance of transesophageal echocardiography (TEE). Data on the safety of intracardiac echocardiogram (ICE)-guided LAAC from a real-world population in the United States remain limited. In this study, the aim was to evaluate the trends and outcomes of ICE-guided LAAC procedures using the US National Inpatient Sample. Methods: This study used the National Inpatient Sample database from quarter 4 of 2015 to 2019. We used a propensity-matched analysis and adjusted odds ratios for in-hospital outcomes/complications. A P value of <.05 was considered significant. Results: We identified 61,995 weighted LAAC cases. Of these, 1410 patients had ICE-guided LAAC with a lower median age than the patients who had TEE-guided LAAC (75 vs 77 years; P ≤ .01). The use of ICE-guided LAAC increased from 1.7% in 2015 to 2.2% in 2019 (P trend = .75). Major, cardiovascular, neurologic, and pulmonary complications were similar for ICE-guided and TEE-guided LAAC on adjusted analysis. On propensity-matched analysis, the overall vascular complication rates were similar. However, retroperitoneal bleeding remained significantly higher (0.7% vs 0%) with ICE. Gastrointestinal bleeding complications were more frequent in TEE-guided LAAC (3.5% vs 2.1%). The length of stay was similar for both groups (median = 1 day; P = .23); however, ICE was associated with $1769 excess cost of hospitalization ($25,112 vs $23,343; P = .04). Conclusions: ICE-guided LAAC is safer than TEE-guided LAAC, with similar rates of major complications. However, ICE use was associated with lower rates of gastrointestinal bleeding and higher rates of retroperitoneal bleeding. In addition, ICE-guided LAAC is associated with a similar length of stay but higher costs of hospitalization.