Transcatheter Valve Replacement in Severe Tricuspid Regurgitation.

BACKGROUND: Severe tricuspid regurgitation is associated with disabling symptoms and an increased risk of death. Data regarding outcomes after percutaneous transcatheter tricuspid-valve replacement are needed. METHODS: In this international, multicenter trial, we randomly assigned 400 patients with severe symptomatic tricuspid regurgitation in a 2:1 ratio to undergo either transcatheter tricuspid-valve replacement and medical therapy (valve-replacement group) or medical therapy alone (control group). The hierarchical composite primary outcome was death from any cause, implantation of a right ventricular assist device or heart transplantation, postindex tricuspid-valve intervention, hospitalization for heart failure, an improvement of at least 10 points in the score on the Kansas City Cardiomyopathy Questionnaire overall summary (KCCQ-OS), an improvement of at least one New York Heart Association (NYHA) functional class, and an improvement of at least 30 m on the 6-minute walk distance. A win ratio was calculated for the primary outcome by comparing all possible patient pairs, starting with the first event in the hierarchy. RESULTS: A total of 267 patients were assigned to the valve-replacement group and 133 to the control group. At 1 year, the win ratio favoring valve replacement was 2.02 (95% confidence interval [CI], 1.56 to 2.62; P<0.001). In comparisons of patient pairs, those in the valve-replacement group had more wins than the control group with respect to death from any cause (14.8% vs. 12.5%), postindex tricuspid-valve intervention (3.2% vs. 0.6%), and improvement in the KCCQ-OS score (23.1% vs. 6.0%), NYHA class (10.2% vs. 0.8%), and 6-minute walk distance (1.1% vs. 0.9%). The valve-replacement group had fewer wins than the control group with respect to the annualized rate of hospitalization for heart failure (9.7% vs. 10.0%). Severe bleeding occurred in 15.4% of the valve-replacement group and in 5.3% of the control group (P = 0.003); new permanent pacemakers were implanted in 17.4% and 2.3%, respectively (P<0.001). CONCLUSIONS: For patients with severe tricuspid regurgitation, transcatheter tricuspid-valve replacement was superior to medical therapy alone for the primary composite outcome, driven primarily by improvements in symptoms and quality of life. (Funded by Edwards Lifesciences; TRISCEND II ClinicalTrials.gov number, NCT04482062.).

Five-Year Follow-up after Transcatheter Repair of Secondary Mitral Regurgitation.

BACKGROUND: Data from a 5-year follow-up of outcomes after transcatheter edge-to-edge repair of severe mitral regurgitation, as compared with outcomes after maximal doses of guideline-directed medical therapy alone, in patients with heart failure are now available. METHODS: We randomly assigned patients with heart failure and moderate-to-severe or severe secondary mitral regurgitation who remained symptomatic despite the use of maximal doses of guideline-directed medical therapy to undergo transcatheter edge-to-edge repair plus receive medical therapy (device group) or to receive medical therapy alone (control group) at 78 sites in the United States and Canada. The primary effectiveness end point was all hospitalizations for heart failure through 2 years of follow-up. The annualized rate of all hospitalizations for heart failure, all-cause mortality, the risk of death or hospitalization for heart failure, and safety, among other outcomes, were assessed through 5 years. RESULTS: Of the 614 patients enrolled in the trial, 302 were assigned to the device group and 312 to the control group. The annualized rate of hospitalization for heart failure through 5 years was 33.1% per year in the device group and 57.2% per year in the control group (hazard ratio, 0.53; 95% confidence interval [CI], 0.41 to 0.68). All-cause mortality through 5 years was 57.3% in the device group and 67.2% in the control group (hazard ratio, 0.72; 95% CI, 0.58 to 0.89). Death or hospitalization for heart failure within 5 years occurred in 73.6% of the patients in the device group and in 91.5% of those in the control group (hazard ratio, 0.53; 95% CI, 0.44 to 0.64). Device-specific safety events within 5 years occurred in 4 of 293 treated patients (1.4%), with all the events occurring within 30 days after the procedure. CONCLUSIONS: Among patients with heart failure and moderate-to-severe or severe secondary mitral regurgitation who remained symptomatic despite guideline-directed medical therapy, transcatheter edge-to-edge repair of the mitral valve was safe and led to a lower rate of hospitalization for heart failure and lower all-cause mortality through 5 years of follow-up than medical therapy alone. (Funded by Abbott; COAPT ClinicalTrials.gov number, NCT01626079.).

Mitral valve-in-valve with 4D intracardiac echocardiography: Procedural and imaging technique.

Transcatheter mitral valve-in-valve (ViV) has emerged as a safe and effective therapeutic option for patients with a degenerated mitral bioprosthesis. As procedural techniques mature and operator experience improve, there is a push to adopt a "minimalist" approach of using conscious sedation instead of general anesthesia for faster recovery. The heavy reliance on fluoroscopy for ViV deployment makes feasible the use of intracardiac echocardiography (ICE) instead of transesophageal echocardiography for other procedural imaging requirements. We hereby use a case example to illustrate a step-by-step approach of using four-dimensional ICE to guide transcatheter mitral ViV under conscious sedation.

A modified Carpentier classification in transcatheter edge-to-edge repair for mitral regurgitation.

Mitral regurgitation (MR) is the most common heart valve disease, and transcatheter edge-to-edge repair (TEER) has been recommended as a therapy for severe MR patients by guidelines. The classic Carpentier classification used to guide surgical mitral valve repair but is inadequate for mitral TEER (M-TEER). We herein proposed a new modified Carpentier classification named after "type + segment," which is suitable for M-TEER. We shared our strategies in M-TEER procedure for screening and performing the M-TEER according to the new modified Carpentier classification.

Transcatheter Left Ventricular Restoration in Patients With Heart Failure.

BACKGROUND: Left ventricular (LV) volume reshaping reduces myocardial wall stress and may induce reverse remodeling in patients with heart failure with reduced ejection fraction. The AccuCinch Transcatheter Left Ventricular Restoration system consists of a series of anchors connected by a cable implanted along the LV base that is cinched to the basal free wall radius. We evaluated the echocardiographic and clinical outcomes following transcatheter left ventricular restoration. METHODS AND RESULTS: We analyzed 51 heart failure patients with a left ventricular ejection fraction between 20% and 40%, with no more than 2+ mitral regurgitation treated with optimal medical therapy, who subsequently underwent transcatheter left ventricular restoration. Serial echocardiograms, Kansas City Cardiomyopathy Questionnaire scores, and 6-minute walk test distances were measured at baseline through 12 months. Primary analysis end point was change in end-diastolic volume at 12 months compared with baseline. Patients (n = 51) were predominantly male (86%) with a mean age of 56.3 ± 13.1 years. Fluoroscopy showed LV free wall radius decreased by a median of 9.2 mm amounting to a 29.6% decrease in the free wall arc length. At 12 months, the LV end-diastolic volume decreased by 33.6 ± 34.8 mL (P < .01), with comparable decreases in the LV end-systolic volume. These decreases were associated with significant improvements in the overall Kansas City Cardiomyopathy Questionnaire score (16.4 ± 18.7 points; P < .01) and 6-minute hall walk test distance (45.9 ± 83.9 m; P < .01). There were no periprocedural deaths; through the 1-year follow-up, 1 patient died (day 280) and 1 patient received a left ventricular assist device (day 13). CONCLUSIONS: In patients with heart failure with reduced ejection fraction without significant mitral regurgitation receiving optimal medical therapy, the AccuCinch System resulted in decreases of LV volume, as well as improved quality of life and exercise endurance. A randomized trial is ongoing (NCT04331769).

Preemptive alcohol septal ablation prior to transcatheter mitral valve replacement.

BACKGROUND: Alcohol septal ablation (ASA) has been shown to increase the neo-left ventricular outflow tract (LVOT) area before transcatheter mitral valve replacement (TMVR) but there is little literature on its success and use with dedicated devices. AIMS: To describe our experience with preemptive ASA to increase the predicted neo-LVOT area and its utility with both dedicated TMVR devices and balloon-expandable valves. METHODS: All patients who underwent ASA for TMVR candidacy in our center between May 2018 and October 2022 and had computed tomography (CT) scans done before and after ASA were included. Each CT was assessed for the minimum predicted neo-LVOT area at end-systole, using a virtual valve of the desired TMVR device for each patient. The primary outcome was an increase in the predicted neo-LVOT area after ASA that was deemed sufficient for safe implantation of the desired TMVR device. The secondary outcome was the absence of acute LVOT obstruction after TMVR. RESULTS: A total of 12 patients underwent ASA and all but 1 (n = 11, 91.6%) achieved the primary outcome of having sufficient predicted neo-LVOT area to proceed with TMVR. The mean increase in neo-LVOT area after ASA was 126 ± 64 mm2 (median 119.5, interquartile range: 65.0-163.5 mm2 ). Two patients (16.7%) required a permanent pacemaker after ASA. Nine patients went on and underwent TMVR with their respective devices and none had LVOT obstruction after the procedure. Among the remaining three patients, one had insufficient neo-LVOT clearance after ASA, one had unrelated mortality before TMVR, and one had advanced heart failure before TMVR. CONCLUSION: In appropriately selected patients and at centers experienced with ASA, preemptive ASA can achieve sufficient neo-LVOT clearance for TMVR with a variety of devices in approximately 90% of patients.

Three-year outcomes for transcatheter repair in patients with mitral regurgitation from the CLASP study.

BACKGROUND: Mitral valve transcatheter edge-to-edge repair (M-TEER) is an effective option for treatment of mitral regurgitation (MR). We previously reported favorable 2-year outcomes for the PASCAL transcatheter valve repair system. OBJECTIVES: We report 3-year outcomes from the multinational, prospective, single-arm CLASP study with analysis by functional MR (FMR) and degenerative MR (DMR). METHODS: Patients with core-lab determined MR ≥ 3+ were deemed candidates for M-TEER by the local heart team. Major adverse events were assessed by an independent clinical events committee to 1 year and by sites thereafter. Echocardiographic outcomes were evaluated by the core laboratory to 3 years. RESULTS: The study enrolled 124 patients, 69% FMR; 31% DMR (60% NYHA class III-IVa, 100% MR ≥ 3+). The 3-year Kaplan-Meier estimate for survival was 75% (66% FMR; 92% DMR) and freedom from heart failure hospitalization (HFH) was 73% (64% FMR; 91% DMR), with 85% reduction in annualized HFH rate (81% FMR; 96% DMR) (p < 0.001). MR ≤ 2+ was achieved and maintained in 93% of patients (93% FMR; 94% DMR) and MR ≤ 1+ in 70% of patients (71% FMR; 67% DMR) (p < 0.001). The mean left ventricular end-diastolic volume (181 mL at baseline) decreased progressively by 28 mL [p < 0.001]. NYHA class I/II was achieved in 89% of patients (p < 0.001). CONCLUSIONS: The 3-year results from the CLASP study demonstrated favorable and durable outcomes with the PASCAL transcatheter valve repair system in patients with clinically significant MR. These results add to the growing body of evidence establishing the PASCAL system as a valuable therapy for patients with significant symptomatic MR.

Percutaneous Mitral Valve Repair in Pediatric Patients.

Rigorous clinical trials have demonstrated the safety and efficacy of Transcatheter Edge-to-Edge Repair to treat severe secondary mitral regurgitation (MR) in adults with primary cardiomyopathy who have failed guideline-directed medical therapy, as well as those with primary MR at high surgical risk. To date, there are only three case reports describing this procedure in the pediatric population. We report a case series of four pediatric patients, including the youngest and smallest reported, who underwent this procedure.

Relationship Between Residual Mitral Regurgitation and Clinical and Quality-of-Life Outcomes After Transcatheter and Medical Treatments in Heart Failure: COAPT Trial.

BACKGROUND: In the randomized COAPT trial (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation), among 614 patients with heart failure with 3+ or 4+ secondary mitral regurgitation (MR), transcatheter mitral valve repair (TMVr) with the MitraClip reduced MR, heart failure hospitalizations, and mortality and improved quality of life compared with guideline-directed medical therapy (GDMT) alone. We aimed to examine the prognostic relationship between MR reduction and outcomes after TMVr and GDMT alone. METHODS: Outcomes in COAPT between 30 days and 2 years were examined on the basis of the severity of residual MR at 30 days. RESULTS: TMVr-treated patients had less severe residual MR at 30 days than GDMT-treated patients (0/1+, 2+, and 3+/4+: 72.9%, 19.9%, and 7.2% versus 8.2%, 26.1%, and 65.8%, respectively [P<0.0001]). The rate of composite death or heart failure hospitalizations between 30 days and 2 years was lower in patients with 30-day residual MR of 0/1+ and 2+ compared with patients with 30-day residual MR of 3+/4+ (37.7% versus 49.5% versus 72.2%, respectively [P<0.0001]). This relationship was consistent in the TMVr and GDMT arms (Pinteraction=0.92). The improvement in Kansas City Cardiomyopathy Questionnaire score from baseline to 30 days was maintained between 30 days and 2 years in patients with 30-day MR ≤2+ but deteriorated in those with 30-day MR 3+/4+ (-0.3±1.7 versus -9.4±4.6 [P=0.0008]) consistently in both groups (Pinteraction=0.95). CONCLUSIONS: In the COAPT trial, reduced MR at 30 days was associated with greater freedom from death or heart failure hospitalizations and improved quality of life through 2-year follow-up whether the MR reduction was achieved by TMVr or GDMT. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01626079.

Transcatheter Mitral-Valve Repair in Patients with Heart Failure.

BACKGROUND: Among patients with heart failure who have mitral regurgitation due to left ventricular dysfunction, the prognosis is poor. Transcatheter mitral-valve repair may improve their clinical outcomes. METHODS: At 78 sites in the United States and Canada, we enrolled patients with heart failure and moderate-to-severe or severe secondary mitral regurgitation who remained symptomatic despite the use of maximal doses of guideline-directed medical therapy. Patients were randomly assigned to transcatheter mitral-valve repair plus medical therapy (device group) or medical therapy alone (control group). The primary effectiveness end point was all hospitalizations for heart failure within 24 months of follow-up. The primary safety end point was freedom from device-related complications at 12 months; the rate for this end point was compared with a prespecified objective performance goal of 88.0%. RESULTS: Of the 614 patients who were enrolled in the trial, 302 were assigned to the device group and 312 to the control group. The annualized rate of all hospitalizations for heart failure within 24 months was 35.8% per patient-year in the device group as compared with 67.9% per patient-year in the control group (hazard ratio, 0.53; 95% confidence interval [CI], 0.40 to 0.70; P<0.001). The rate of freedom from device-related complications at 12 months was 96.6% (lower 95% confidence limit, 94.8%; P<0.001 for comparison with the performance goal). Death from any cause within 24 months occurred in 29.1% of the patients in the device group as compared with 46.1% in the control group (hazard ratio, 0.62; 95% CI, 0.46 to 0.82; P<0.001). CONCLUSIONS: Among patients with heart failure and moderate-to-severe or severe secondary mitral regurgitation who remained symptomatic despite the use of maximal doses of guideline-directed medical therapy, transcatheter mitral-valve repair resulted in a lower rate of hospitalization for heart failure and lower all-cause mortality within 24 months of follow-up than medical therapy alone. The rate of freedom from device-related complications exceeded a prespecified safety threshold. (Funded by Abbott; COAPT ClinicalTrials.gov number, NCT01626079 .).

Early outcomes from the CLASP IID trial roll-in cohort for prohibitive risk patients with degenerative mitral regurgitation.

OBJECTIVES: We report the 30-day outcomes from the roll-in cohort of the CLASP IID trial, representing the first procedures performed by each site. BACKGROUND: The currently enrolling CLASP IID/IIF pivotal trial is a multicenter, prospective, randomized trial assessing the safety and effectiveness of the PASCAL transcatheter valve repair system in patients with clinically significant MR. The trial allows for up to three roll-in patients per site. METHODS: Eligibility criteria were: DMR ≥3+, prohibitive surgical risk, and deemed suitable for transcatheter repair by the local heart team. Trial oversight included a central screening committee and echocardiographic core laboratory. The primary safety endpoint was a 30-day composite MAE: cardiovascular mortality, stroke, myocardial infarction (MI), new need for renal replacement therapy, severe bleeding, and non-elective mitral valve re-intervention, adjudicated by an independent clinical events committee. Thirty-day echocardiographic, functional, and quality of life outcomes were assessed. RESULTS: A total of 45 roll-in patients with mean age of 83 years and 69% in NYHA class III/IV were treated. Successful implantation was achieved in 100%. The 30-day composite MAE rate was 8.9% including one cardiovascular death (2.2%) due to severe bleeding from a hemorrhagic stroke, one MI, and no need for re-intervention. MR≤1+ was achieved in 73% and ≤2+ in 98% of patients. 89% of patients were in NYHA class I/II (p < .001) with improvements in 6MWD (30 m; p = .054) and KCCQ (17 points; p < .001). CONCLUSIONS: Early results representing sites with first experience with the PASCAL repair system showed favorable 30-day outcomes in patients with DMR≥3+ at prohibitive surgical risk.

One-Year Outcomes After MitraClip for Functional Mitral Regurgitation.

BACKGROUND: Secondary mitral regurgitation (SMR) occurs in the absence of organic mitral valve disease and may develop as the left ventricle dilates or remodels or as a result of leaflet tethering with impaired coaptation, most commonly from apical and lateral distraction of the subvalvular apparatus, with late annular dilatation. The optimal therapy for SMR is unclear. This study sought to evaluate the 1-year adjudicated outcomes of all patients with SMR undergoing the MitraClip procedure in the EVEREST II (Endovascular Valve Edge-to-Edge Repair Study) Investigational Device Exemption program, which is comprised of the randomized clinical trial, the prospective High-Risk Registry, and the REALISM Continued Access Registry (Multicenter Study of the MitraClip System). METHODS: Patients with 3+/4+ SMR enrolled in EVEREST II were stratified by non-high surgical risk (non-HR) and high surgical risk (HR) status (defined as Society of Thoracic Surgeons risk of mortality ≥12% or predefined risk factors). Clinical, echocardiographic, and functional outcomes at 1 year were evaluated. RESULTS: A total of 616 patients (482 HR, 134 non-HR; mean age, 73.3±10.5 years; Society of Thoracic Surgeons risk, 10.2±6.9%) with SMR underwent the MitraClip procedure. At baseline, 80.5% of patients were in New York Heart Association class III/IV. Major adverse events at 30 days included death (3.6%), stroke (2.3%), and renal failure (1.5%). At discharge, 88.8% had MR ≤2+. At 1 year, there were 139 deaths, and the Kaplan-Meier estimate of freedom from mortality was 76.8%. The majority of surviving patients (84.7%) remained with MR ≤2+ and New York Heart Association class I/II (83.0%). Kaplan-Meier survival at 1 year was 74.1% in HR patients and 86.4% in non-HR patients ( P=0.0175). At 1 year, both groups achieved comparable MR reduction (MR ≤2+, 84.0% versus 87.0%) and improvement in left ventricular end-diastolic volume (-8.0 mL versus -12.7 mL), whereas New York Heart Association class I/II was found in 80.1% versus 91.8% ( P=0.008) of HR and non-HR patients, respectively. In HR patients, the annualized rate of heart failure hospitalizations decreased from 0.68 to 0.46 in the 12 months before to 12 months after the procedure ( P<0.0001). CONCLUSIONS: Transcatheter mitral valve repair with the MitraClip in patients with secondary MR is associated with acceptable safety, reduction of MR severity, symptom improvement, and positive ventricular remodeling. CLINICAL TRIAL REGISTRATION: https://www.clinicaltrials.gov . Unique identifiers: NCT00209274, NCT01940120, and NCT01931956.

Cardiovascular Outcomes Assessment of the MitraClip in Patients with Heart Failure and Secondary Mitral Regurgitation: Design and rationale of the COAPT trial.

BACKGROUND: Patients with heart failure (HF) and symptomatic secondary mitral regurgitation (SMR) have a poor prognosis, with morbidity and mortality directly correlated with MR severity. Correction of isolated SMR with surgery is not well established in this population, and medical management remains the preferred approach in most patients. The Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (COAPT) trial was designed to determine whether transcatheter mitral valve (MV) repair with the MitraClip device is safe and effective in patients with symptomatic HF and clinically significant SMR. STUDY DESIGN: The COAPT trial is a prospective, randomized, parallel-controlled, open-label multicenter study of the MitraClip device for the treatment of moderate-to-severe (3+) or severe (4+) SMR (as verified by an independent echocardiographic core laboratory) in patients with New York Heart Association class II-IVa HF despite treatment with maximally tolerated guideline-directed medical therapy (GDMT) who have been determined by the site's local heart team as not appropriate for MV surgery. A total of 614 eligible subjects were randomized in a 1:1 ratio to MV repair with the MitraClip plus GDMT versus GDMT alone. The primary effectiveness end point is recurrent HF hospitalizations through 24 months, analyzed when the last subject completes 12-month follow-up, powered to demonstrate superiority of MitraClip therapy. The primary safety end point is a composite of device-related complications at 12 months compared to a performance goal. Follow-up is ongoing, and the principal results are expected in late 2018. CONCLUSIONS: HF patients with clinically significant SMR who continue to be symptomatic despite optimal GDMT have limited treatment options and a poor prognosis. The randomized COAPT trial was designed to determine the safety and effectiveness of transcatheter MV repair with the MitraClip in symptomatic HF patients with moderate-to-severe or severe SMR.

6-Minute walk test predicts prolonged hospitalization in patients undergoing transcatheter mitral valve repair by MitraClip.

BACKGROUND: The 6-minute walk test (6MWT) is a simple functional test that can predict exercise capacity and is widely employed to assess treatment outcomes. Although mortality with transcatheter mitral valve repair (TMVr) using the MitraClip (Abbott Vascular, Menlo Park, CA) is significantly less than for open mitral valve surgery in high-risk patients, identifying which patient will benefit the most from TMVr remains a concern. There are limited prognostic metrics guiding patient selection and, no studies have reported relationship between prolonged hospitalization and 6MWT. This study aimed to determine if the 6MWT can predict prolonged hospitalization in patients undergoing TMVr by MitraClip. METHODS: We retrospectively reviewed 162 patients undergoing 6MWT before TMVr. Patients were divided into three groups according to the 6MWT distance (6MWTD) using the median (6MWTD ≥219 m, 6MWTD <219 m, and Unable to Walk). Multivariate logistic regression model was applied to select the demographic characteristics that were associated with the prolonged hospitalization defined as total length of stay ≥4 days in the study. RESULTS: We found that 6MWT (odds ratio 3.64, 95% confidence interval 2.03-6.52, P < 0.001) was independently associated with prolonged hospitalization after adjustment in multivariate analysis. Area under the curve of 6MWT for predicting prolonged hospitalization was 0.79 (95% confidence interval 0.72-0.85). CONCLUSIONS: Our study demonstrates that 6MWT was independently associated with prolonged hospitalization in patients with TMVr, and has a good discriminatory performance for predicting prolonged hospitalization.

Use of intracardiac echocardiography to guide percutaneous transluminal mitral commissurotomy: A 20-patient case series.

OBJECTIVES: To report the efficacy and safety of the use adjunctive intracardiac echocardiography (ICE) during percutaneous transluminal mitral commissurotomy (PTMC) in patients without transesophageal echocardiography (TEE). BACKGROUND: Patients with mitral stenosis are at a high risk of developing a left atrial (LA) thrombus. Traditionally, TEE has been used prior to PTMC to identify the presence of LA thrombi. There have been no reports of the use of ICE to assess the LA for thrombi prior to PTMC. METHODS: We retrospectively reviewed 20 patients who underwent ICE prior to PTMC. All PTMC procedures were performed via the antegrade transvenous approach using an Inoue balloon. Initially, ICE was used from the right atrium to confirm the absence of a thrombus on the left side of the septum and was subsequently used to guide the transseptal puncture. Following these procedures, the ICE was advanced into the LA through a transseptal sheath to visualize the LAA. RESULTS: Visualization of the thrombus/spontaneous echo contrast was considered to be diagnostic in all cases. Seventy percent of the patients were discharged on day after the procedure. No patients required intubation during the procedure, and there were no complications that could be attributed to the use of ICE. At six months after the PTMC, the incidence of stroke was zero. CONCLUSIONS: ICE-guided PTMC offers excellent visualization of the LA and the LAA with satisfactory clinical outcomes and low risk. As a part of the PTMC procedure, ICE safely provides a valid alternative to a separate TEE procedure.

Adjunctive intracardiac echocardiography imaging from the left ventricle to guide percutaneous mitral valve repair with the MitraClip in patients with failed prior surgical rings.

OBJECTIVES: We evaluated intracardiac echocardiography (ICE) for adjunctively guiding the MitraClip procedure in patients with prior surgical rings. BACKGROUND: Transesophageal echocardiography (TEE) is the standard imaging modality used to guide the MitraClip procedure (Abbott Vascular, CA). However, in patients with post-surgical anatomy, clear imaging of the mitral valve leaflets may be complex because of shadowing from the surgical ring. In these patients, TEE may be suboptimal for guiding the procedure, even using three-dimensional imaging. METHODS: This retrospective analysis included data from 121 consecutive patients with mitral regurgitation who underwent MitraClip procedures at the University of Virginia. ICE was used adjunctively when there was difficulty with TEE, particularly for assessing the insertion of the posterior leaflet into the MitraClip's arms. The ICE catheter was introduced transarterially into the left ventricle and flexed to obtain the short-axis view. RESULTS: Six patients had prior surgical rings, and in five, we used adjunctive ICE. The etiology of the mitral regurgitation was prolapse of the posterior leaflet in one patient and restriction of the posterior leaflet due to ischemic tethering in the remainder. All images were obtained from the left ventricle, and were adequate for assessing posterior leaflet insertion and the perpendicularity of the MitraClip arms. The procedural success rate was 80%. There was no adverse event related to the ICE procedure. CONCLUSIONS: Mitral valve repair with the MitraClip system assisted by ICE is feasible in patients with prior surgical rings, achieving an excellent risk profile and satisfactory procedural success.

Transcatheter Aortic Valve Replacement in Lower Surgical Risk Patients: Review of Major Trials and Future Perspectives.

Following the first successful transcatheter aortic valve replacement (TAVR) in 2002, TAVR has globally evolved to become a standard procedure in high-risk patients. Surgical aortic valve replacement in non-high-risk patients remains the gold standard for treatment of severe aortic stenosis. However, a paradigm shift appears to be occurring in the direction of treating lower-risk patients, and several studies have suggested its impact on clinical outcomes. In this review, we highlight the current status of TAVR in intermediate-risk patients and review major trials including Placement of AoRTic TraNscathetER (PARTNER) 2A randomized intermediate-risk trial using SAPIEN XT (Edwards Lifesciences Corp, Irvine, CA) recently presented with excellent outcomes and the lowest major complications rate at the American College of Cardiology's 65th Annual Scientific Session in Chicago. Clinical trials in low-risk patients using SAPIEN 3 and CoreValve Evolut R have just been launched, and they are going to be important milestones in the TAVR field.

Retrieval of Embolized Transcatheter Aortic Valves in Left Ventricle Through Apical Ventriculotomy.

Transcatheter valve placement complicated by left ventricular embolization is often treated with sternotomy, valve removal through the aorta, and conventional aortic valve replacement. We report three cases of ventricular embolization of aortic valves during deployment. We successfully placed a second transcatheter aortic valve in the correct position and retrieved the embolized valve through an apical ventriculotomy. All patients recovered well and survived for more than one year. doi: 10.1111/jocs.12701 (J Card Surg 2016;31:203-205).

Management of severe aortic regurgitation in a patient with cardiogenic shock using a percutaneous left ventricular assist device and transcatheter occlusion of the failed aortic valve homograft as a bridge to surgical valve replacement.

Acute hemodynamic compromise due to severe aortic regurgitation remains a difficult problem. The optimal management strategy and timing of surgery continues to evolve as new technologies become available. Here, we report the case of a young woman presenting with severe regurgitation of an aortic homograft who developed precipitous cardiogenic shock and multi-organ dysfunction. Her mortality risk with emergent surgery was prohibitive, and no percutaneous valve-in-valve device was available. We stabilized her condition by placing an Amplatz-type Atrial Septal Defect (ASD) occluder across her aortic valve in conjunction with a percutaneous left ventricular assist device as a bridge to surgical valve replacement. She went on to a successful surgery and recovered well.