Impact of Tricuspid Regurgitation on Outcomes After Transcatheter Mitral Valve Replacement.

Development of functional tricuspid regurgitation (TR) because of chronic mitral disease and subsequent heart failure is common. However, the effect of TR on clinical outcomes after transcatheter mitral valve replacement (TMVR) remains unclear. We aimed to evaluate the impact of baseline TR on outcomes after TMVR. This was a single-center, retrospective analysis of patients who received valve-in-valve or valve-in-ring TMVR between 2012 and 2022. Patients were categorized into none/mild TR and moderate/severe TR based on baseline echocardiography. The primary outcome was 3 years all-cause death and the secondary outcomes were in-hospital events. Of the 135 patients who underwent TMVR, 64 (47%) exhibited none/mild TR at baseline, whereas 71 (53%) demonstrated moderate/severe TR. There were no significant differences in in-hospital events between the groups. At 3 years, the moderate/severe TR group exhibited a significantly increased risk of all-cause death (adjusted hazard ratio 3.37, 95% confidence interval 1.35 to 8.41, p = 0.009). When patients with baseline moderate/severe TR were stratified by echocardiography at 30 days into improved (36%) and nonimproved (64%) TR groups, although limited by small sample size, there was no significant difference in 3-year all-cause mortality (p = 0.48). In conclusion, this study investigating the impact of baseline TR on clinical outcomes revealed that moderate/severe TR is prevalent in those who underwent TMVR and is an independent predictor of 3-year all-cause mortality. Earlier mitral valve intervention before the development of significant TR may play a pivotal role in improving outcomes after TMVR.

Transcatheter Myotomy to Reduce Left Ventricular Outflow Obstruction.

BACKGROUND: Left ventricular outflow tract (LVOT) obstruction is a source of morbidity in hypertrophic cardiomyopathy (HCM) and a life-threatening complication of transcatheter mitral valve replacement (TMVR) and transcatheter aortic valve replacement (TAVR). Available surgical and transcatheter approaches are limited by high surgical risk, unsuitable septal perforators, and heart block requiring permanent pacemakers. OBJECTIVES: The authors report the initial experience of a novel transcatheter electrosurgical procedure developed to mimic surgical myotomy. METHODS: We used septal scoring along midline endocardium (SESAME) to treat patients, on a compassionate basis, with symptomatic LVOT obstruction or to create space to facilitate TMVR or TAVR. RESULTS: In this single-center retrospective study between 2021 and 2023, 76 patients underwent SESAME. In total, 11 (14%) had classic HCM, and the remainder underwent SESAME to facilitate TMVR or TAVR. All had technically successful SESAME myocardial laceration. Measures to predict post-TMVR LVOT significantly improved (neo-LVOT 42 mm2 [Q1-Q3: 7-117 mm2] to 170 mm2 [Q1-Q3: 95-265 mm2]; P < 0.001; skirt-neo-LVOT 169 mm2 [Q1-Q3: 153-193 mm2] to 214 mm2 [Q1-Q3: 180-262 mm2]; P < 0.001). Among patients with HCM, SESAME significantly decreased invasive LVOT gradients (resting: 54 mm Hg [Q1-Q3: 40-70 mm Hg] to 29 mm Hg [Q1-Q3: 12-36 mm Hg]; P = 0.023; provoked 146 mm Hg [Q1-Q3: 100-180 mm Hg] to 85 mm Hg [Q1-Q3: 40-120 mm Hg]; P = 0.076). A total of 74 (97.4%) survived the procedure. Five experienced 3 of 76 (3.9%) iatrogenic ventricular septal defects that did not require repair and 3 of 76 (3.9%) ventricular free wall perforations. Neither occurred in patients treated for HCM. Permanent pacemakers were required in 4 of 76 (5.3%), including 2 after concomitant TAVR. Lacerations were stable and did not propagate after SESAME (remaining septum: 5.9 ± 3.3 mm to 6.1 ± 3.2 mm; P = 0.8). CONCLUSIONS: With further experience, SESAME may benefit patients requiring septal reduction therapy for obstructive hypertrophic cardiomyopathy as well as those with LVOT obstruction after heart valve replacement, and/or can help facilitate transcatheter valve implantation.

Left Ventricular Outflow Tract Modification for Transcatheter Mitral Valve Replacement.

Left ventricular outflow tract (LVOT) obstruction is a life-threatening complication of transcatheter mitral valve replacement. In-depth analysis of pre-procedural computed tomography enables accurate prediction of this risk. Several techniques for LVOT modification, including Laceration of the Anterior Mitral leaflet to Prevent Outflow ObtructioN, preemptive alcohol septal ablation, preemptive radiofrequency ablation, and Septal Scoring Along the Midline Endocardium, have been described as effective strategies to mitigate this risk. This review aims to explore the indications, procedural steps, and outcomes associated with these LVOT modification techniques.

Transcatheter Paravalvular Leak Closure With Covered Stent Tract and Vascular Plug: Tootsie Roll Technique.

BACKGROUND: Transcatheter closure of transcatheter heart valve (THV)-related paravalvular leak (PVL) is associated with a high failure rate with available devices due to the complex interaction of THV and aortic/mitral annulus. OBJECTIVES: This study reports on novel transcatheter techniques to treat PVL after THV. METHODS: The authors describe consecutive patients who underwent PVL closure after transcatheter aortic valve replacement (TAVR) or transcatheter mitral valve replacement (TMVR). A covered self-expanding stent (Viabahn) was deployed in the defect to create a seal between the THV and annulus. A vascular plug (Amplatzer Vascular Plug 2 [AVP2] or AVP4) was then deployed inside the covered stent to obliterate PVL. RESULTS: Eight patients with THV-related PVL were treated using this method (aortic [3 SAPIEN, 1 Evolut], mitral [2 SAPIEN-in-MAC (mitral annular calcification), 2 M3 TMVR). Various combinations of stents and plugs were used (5 mm × 2.5 cm Viabahn + 6 mm AVP4 [n = 2], 8 mm × 2.5 cm Viabahn + 10 mm AVP2 [n = 5], and 10 mm × 5.0 cm Viabahn + 12 mm AVP2 [n = 1]). All had technical success with immediate elimination of target PVL, without in-hospital complications. None had signs of postprocedure hemolysis. All patients were discharged alive (median 3.5 days [Q1-Q3: 1.0-4.8 days]). No residual PVL was seen at discharge, except for 1 patient with mild regurgitation due to another untreated PVL location. One patient died before 30 days due to complication of valve-in-MAC TMVR. In remaining patients, none had recurrence of PVL at 30 days. Symptoms decreased to NYHA functional class I/II in 6 patients. NYHA functional class III symptoms remained in 1 patient with mitral regurgitation awaiting subsequent valve replacement procedure. CONCLUSIONS: The technique of sequential deployment of a covered stent and vascular plug may effectively treat THV-related PVL.

Transcatheter aortic valve replacement outcomes in patients with low-flow very low-gradient aortic stenosis.

AIMS: In patients with severe aortic stenosis (AS), low-flow low-gradient (LG) is a known predictor of worse outcomes. However, very LG may represent a distinct population with further cardiac dysfunction. It is unknown whether this population benefits from transcatheter aortic valve replacement (TAVR). We aimed to describe the patient characteristics and clinical outcomes of low-flow very LG severe AS. METHODS AND RESULTS: This single-centre study included all patients with low-flow severe AS between 2019 and 2021. Patients were divided into groups with very LG [mean pressure gradient (MPG) ≤ 20 mmHg], LG (20 < MPG < 40 mmHg), and high-gradient (HG) (MPG ≥ 40 mmHg). Composite endpoint of all-cause mortality and heart failure rehospitalization was compared. A total of 662 patients [very LG 130 (20%); LG 339 (51%); HG 193 (29%)] were included. Median follow-up was 12 months. Very LG cohort had a higher prevalence of comorbid conditions with lower left ventricular ejection fraction (45% vs. 57% vs. 60%; P < 0.001). There was a graded increase in the risk of composite endpoint in the lower MPG strata (P < 0.001). Among those who underwent TAVR, very LG was an independent predictor of the composite endpoint (adjusted HR 2.42 [1.29-4.55]). While LG and HG cohorts had decreased risk of composite endpoint after TAVR compared with conservative management, very LG was not associated with risk reduction (adjusted HR 0.69 [0.35-1.34]). CONCLUSION: Low-flow very LG severe AS represents a distinct population with significant comorbidities and worse outcomes. Further studies are needed to evaluate the short- and long-term benefits of TAVR in this population.

Comparison among various physiology and angiography-guided strategies for deferring percutaneous coronary intervention: A network meta-analysis.

BACKGROUND/PURPOSE: It is unclear whether coronary physiology or coronary angiography (CA)-guided strategy is the more preferable approach for deferring percutaneous coronary intervention (PCI). We sought to evaluate the clinical efficacy of various PCI strategies through a network meta-analysis of randomized controlled trials (RCTs). METHODS/MATERIALS: We searched multiple databases for RCTs investigating the impact of the following strategies for the purpose of determining whether or not to defer PCI: fractional flow reserve, instantaneous wave-free ratio, quantitative flow ratio (QFR), and CA. We conducted a network meta-analysis for trial-defined major adverse cardiovascular events (MACE), all-cause death, cardiovascular death, myocardial infarction (MI), target lesion revascularization (TLR), and stent thrombosis. We performed a subgroup analysis for those with acute coronary syndrome (ACS). RESULTS: Our search identified 12 eligible RCTs including a total of 13,177 patients. QFR-guided PCI was associated with reduced MACE, MI, and TLR compared with CA-guided PCI (relative risk (RR) 0.68; 95 % confidence interval (CI] [0.49 to 0.94], RR 0.58; 95 % CI [0.36 to 0.96], and RR 0.58; 95 % CI [0.38 to 0.91], respectively). There were no significant differences in any pairs for all-cause death, cardiovascular death, or stent thrombosis. QFR was ranked the best in most outcomes. In the subgroup analysis of the ACS cohort, there were no significant differences in MACE between any comparisons. CONCLUSIONS: QFR was associated with reduced MACE, MI, and TLR compared with CA, and ranked the best in most outcomes. However, this was not applied in the ACS cohort.

Cardiac Reoperation or Transcatheter Mitral Valve Replacement for Patients With Failed Mitral Prostheses.

BACKGROUND: Evidence is limited regarding patient outcomes comparing redo surgical mitral valve replacement (redo SMVR) vs transcatheter mitral valve replacement (TMVR) for failed prostheses. OBJECTIVES: The goal of this study was to compare the outcomes of redo SMVR vs TMVR in patients with failed prostheses, as well as evaluate the association between case volume and outcomes. METHODS: Medicare beneficiaries aged ≥65 years who underwent redo SMVR or TMVR for failed mitral prostheses between 2016 and 2020 were included. The primary endpoint was mid-term (up to 3 years) major adverse cardiovascular events (MACE), including all-cause death, heart failure rehospitalization, stroke, or reintervention. Propensity score-matched analysis was used. RESULTS: A total of 4,293 patients were included (redo SMVR: 64%; TMVR: 36%). TMVR recipients were older, with a higher comorbidity burden. In matched cohort (n = 1,317 in each group), mid-term risk of MACE was similar (adjusted HR: 0.92; 95% CI: 0.80-1.04; P = 0.2). However, landmark analysis revealed a lower risk of MACE with TMVR in the first 6 months (adjusted HR: 0.75; 95% CI: 0.63-0.88; P < 0.001) albeit with a higher risk beyond 6 months (adjusted HR: 1.28; 95% CI: 1.04-1.58; P = 0.02). Increasing procedural volume was associated with decreased risk of mid-term MACE after redo SMVR (P = 0.001) but not after TMVR (P = 0.3). CONCLUSIONS: In this large cohort of Medicare beneficiaries with failed mitral prostheses, outcomes were similar between redo SMVR and TMVR at 3 years, with TMVR showing a lower initial risk but a higher risk of MACE after 6 months. These findings highlight the importance of striking a balance between surgical risk, anticipated longevity, and hospital expertise when selecting interventions.

Transcatheter edge-to-edge mitral valve repair for mitral regurgitation in patients with cardiogenic shock: A systematic review and meta-analysis.

BACKGROUND: There is currently little evidence for transcatheter edge-to-edge mitral valve repair (TEER) for mitral regurgitation (MR) in patients with cardiogenic shock (CS). Therefore, this study investigated the characteristics and outcomes of CS patients who underwent TEER for MR. METHODS: PubMed, EMBASE were searched in July 2023. Case series and observational studies reporting clinical characteristics and outcomes in CS patients with MR who underwent TEER were included. We performed a one-group meta-analysis using a random effects model. RESULTS: A total of 4060 patients from 7 case series and 5 observational studies were included. The mean age was 68.2 (95% confidence interval [CI]: 64.1-72.2) years, and 41.4% of patients (95% CI: 39.1%-43.7%) were female. Pre-TEER, severe MR was present in 85.3% (95% CI: 76.1%-91.3%) of patients. Mean left ventricular ejection fraction was 36.7% (95% CI: 29.2%-44.2%), and 54.6% (95% CI: 36.9%-71.2%) of patients received mechanical circulatory support. The severity of MR post-TEER was less than 2+ in 88% (95% CI: 87%-89%) of patients. In-hospital mortality was 11% (95% CI: 10%-13%), whereas 30-day and 1-year mortality rates were 15% (95% CI: 13%-16%), and 36% (95% CI: 21%-54%), respectively. CONCLUSIONS: This systematic review and meta-analysis assessed the clinical characteristics and outcomes of TEER in CS patients with MR. TEER for MR in patients with CS has been successful in reducing MR in most of the patients, but with a high mortality rate. Randomized controlled trials of TEER for MR and CS are needed.

Comparison of Intravascular Imaging, Functional, or Angiographically Guided Coronary Intervention.

BACKGROUND: In patients undergoing percutaneous coronary intervention (PCI), it remains unclear whether intravascular imaging guidance or functional guidance is the best strategy to optimize outcomes and if the results are different in patients with vs without acute coronary syndromes (ACS). OBJECTIVES: The purpose of this study was to evaluate clinical outcomes with imaging-guided PCI or functionally guided PCI when compared with conventional angiography-guided PCI. METHODS: We searched PUBMED and EMBASE for randomized controlled trials investigating outcomes with intravascular imaging-guided, functionally guided, or angiography-guided PCI. The primary outcome from this network meta-analysis was trial-defined major adverse cardiovascular event (MACE)-a composite of cardiovascular death, myocardial infarction (MI), and target lesion revascularization (TLR). PCI strategies were ranked (best to worst) using P scores. RESULTS: Our search identified 32 eligible randomized controlled trials and included a total of 22,684 patients. Compared with angiography-guided PCI, intravascular imaging-guided PCI was associated with reduced risk of MACE (relative risk [RR]: 0.72; 95% CI: 0.62-0.82), cardiovascular death (RR: 0.56; 95% CI: 0.42-0.75), MI (RR: 0.81; 95% CI: 0.66-0.99), stent thrombosis (RR: 0.48; 95% CI: 0.31-0.73), and TLR (RR: 0.75; 95% CI: 0.57-0.99). Similarly, when compared with angiography-guided PCI, functionally guided PCI was associated with reduced risk of MACE and MI. Intravascular imaging-guided PCI ranked first for the outcomes of MACE, cardiovascular death, stent thrombosis, and TLR. The results were consistent in the ACS and non-ACS cohorts. CONCLUSIONS: Angiography-guided PCI had consistently worse outcomes compared with intravascular imaging-guided and functionally guided PCI. Intravascular imaging-guided PCI was the best strategy to reduce the risk of cardiovascular events.

Hybrid Closure of Postinfarction Apical Ventricular Septal Defect Using Septal Occluder Device and Right Ventricular Free Wall: The Apical BASSINET Concept.

BACKGROUND: Postinfarction ventricular septal defect (VSD) is a catastrophic complication of myocardial infarction. Surgical repair still has poor outcomes. This report describes clinical outcomes after a novel hybrid transcatheter/surgical repair in patients with apical VSD. METHODS: Seven patients with postmyocardial infarction apical VSD underwent hybrid transcatheter repair via subxiphoid surgical access. A transcatheter occluder (Amplatzer Septal Occluder) with a trailing premounted suture was deployed through the right ventricular wall and through the ventricular septum into the left ventricular apex. The trailing suture was used to connect an anchor external to the right ventricular wall. Tension on the suture then collapses the right ventricular free wall against the septum and left ventricular occluder, thereby obliterating the VSD. Outcomes were compared with 9 patients who underwent surgical repair using either patch or primary suture closure. RESULTS: All patients had significant left-to-right shunt (Qp:Qs 2.5:1; interquartile range [IQR, 2.1-2.6] hybrid repair versus 2.0:1 [IQR, 2.0-2.5] surgical repair), and elevated right ventricular systolic pressure (62 [IQR, 46-71] versus 49 [IQR, 43-54] mm Hg, respectively). All had severely depressed stroke volume index (22 versus 21 mL/m2) with ≈45% in each group requiring mechanical support preprocedurally. The procedure was done 15 (IQR, 10-50) versus 24 (IQR, 10-134) days postmyocardial infarction, respectively. Both groups of patients underwent repair with technical success and without intraprocedural death. One patient in the hybrid group and 4 in the surgical group developed multiorgan failure. The hybrid group had a higher survival at discharge (86% versus 56%) and at 30 days (71% versus 56%), but similar at 1 year (57% versus 56%). During follow-up, 1 patient in each group required reintervention for residual VSD (hybrid: 9 months versus surgical: 5 days). CONCLUSIONS: Early intervention with a hybrid transcatheter/surgical repair may be a viable alternative to traditional surgery for postinfarction apical VSD.

Physician-Modified Endograft-Facilitated Transcatheter Pulmonary Valve Replacement in Large Right Ventricular Outflow Tract.

BACKGROUND: Transcatheter pulmonary valve replacement (TPVR) in patients with a congenital or acquired abnormality resulting in enlarged right ventricular outflow tract (RVOT) is challenging and may preclude treatment with dedicated devices. We describe a technique using a physician-modified endograft to facilitate TPVR. METHODS: Six patients underwent physician-modified endograft-facilitated TPVR for severe symptomatic pulmonary insufficiency with enlarged RVOT. The fenestration was created in a commercially available endograft before implantation, which was then deployed from the dominant branch pulmonary artery into the RVOT, with the fenestration aligned with the ostium of the nondominant pulmonary artery. A covered stent was placed through the fenestration into the nondominant branch pulmonary artery, and a transcatheter heart valve was deployed within the endograft at the level of the original pulmonary valve. RESULTS: Four patients had tetralogy of Fallot, 1 had pulmonary atresia, and 1 had rheumatic valve disease. The RVOT/main pulmonary artery was severely enlarged (diameter, 44.2 [43.5-50.6] mm). All patients had reduced right ventricular (RV) function and dilated RVs (RV end-diastolic volume, 314 [235-316] mL). Successful endograft, covered stent, and transcatheter heart valve deployment were achieved in all cases without stent/valve embolization, vascular complications, or bleeding complications. At 30 days, 1 patient had mild pulmonary insufficiency, while others had none. The RV size measured by echocardiography was significantly reduced after TPVR (RV area, 34.4 [baseline] versus 29.0 [pre-discharge] versus 25.3 [30 days] cm2; P=0.03). During median follow-up of 221.5 (range, 29-652) days, there were no deaths or need for pulmonary valve reintervention. One patient developed severe tricuspid regurgitation due to entrapment of the anterior tricuspid leaflet by the endograft. The patient underwent successful tricuspid replacement and resection of the offending endograft with preservation of the pulmonary valve prosthesis. CONCLUSIONS: Simple fenestration of an off-the-shelf endograft and associated covered stent placement through the fenestration allows TPVR for patients with dysfunctional native or patch-repaired pulmonary valves and RVOT enlargement.

Transcatheter Mitral Valve Replacement in Failed Bioprosthetic Valve, Ring, and Mitral Annular Calcification Associated Mitral Valve Disease Using Balloon Expandable Transcatheter Heart Valve.

Transcatheter mitral valve replacement (TMVR) using the SAPIEN platform has been performed in failed bioprosthetic valves (valve-in-valve), surgical annuloplasty rings (valve-in-ring), and native valves with mitral annular calcification (MAC) (valve-in-MAC). Experience over the past decade has identified important challenges and solutions to improve clinical outcomes. In this review, we discuss the indication, trend in utilization, unique challenges, procedural planning, and clinical outcomes of valve-in-valve, valve-in-ring, and valve-in-MAC TMVR.