D. Scott Lim

Acute and 12-Month Results With Catheter-Based Mitral Valve Leaflet Repair : The EVEREST II (Endovascular Valve Edge-to-Edge Repair) High Risk Study

OBJECTIVES The EVEREST II (Endovascular Valve Edge-to-Edge Repair) High Risk Study (HRS) assessed the safety and effectiveness of the MitraClip device (Abbott Vascular, Santa Clara, California) in patients with significant mitral regurgitation (MR) at high risk of surgical mortality rate. BACKGROUND Patients with severe MR (3 to 4+) at high risk of surgery may benefit from percutaneous mitral leaflet repair, a potentially safer approach to reduce MR. METHODS Patients with severe symptomatic MR and an estimated surgical mortality rate of ≥12% were enrolled. A comparator group of patients screened concurrently but not enrolled were identified retrospectively and consented to compare survival in patients treated by standard care. RESULTS Seventy-eight patients underwent the MitraClip procedure. Their mean age was 77 years, >50% had previous cardiac surgery, and 46 had functional MR and 32 degenerative MR. MitraClip devices were successfully placed in 96% of patients. Protocol-predicted surgical mortality rate in the HRS and concurrent comparator group was 18.2% and 17.4%, respectively, and Society of Thoracic Surgeons calculator estimated mortality rate was 14.2% and 14.9%, respectively. The 30-day procedure-related mortality rate was 7.7% in the HRS and 8.3% in the comparator group (p = NS). The 12-month survival rate was 76% in the HRS and 55% in the concurrent comparator group (p = 0.047). In surviving patients with matched baseline and 12-month data, 78% had an MR grade of ≤2+. Left ventricular end-diastolic volume improved from 172 ml to 140 ml and end-systolic volume improved from 82 ml to 73 ml (both p = 0.001). New York Heart Association functional class improved from III/IV at baseline in 89% to class I/II in 74% (p < 0.0001). Quality of life was improved (Short Form-36 physical component score increased from 32.1 to 36.1 [p = 0.014] and the mental component score from 45.5 to 48.7 [p = 0.065]) at 12 months. The annual rate of hospitalization for congestive heart failure in surviving patients with matched data decreased from 0.59 to 0.32 (p = 0.034). CONCLUSIONS The MitraClip device reduced MR in a majority of patients deemed at high risk of surgery, resulting in improvement in clinical symptoms and significant left ventricular reverse remodeling over 12 months. (Pivotal Study of a Percutaneous Mitral Valve Repair System [EVEREST II]; NCT00209274).

Percutaneous Mitral Valve Repair for Mitral Regurgitation in High-Risk Patients: Results of the EVEREST II Study

BACKGROUND The EVEREST II (Endovascular Valve Edge-to-Edge REpair STudy) High-Risk registry and REALISM Continued Access Study High-Risk Arm are prospective registries of patients who received the MitraClip device (Abbott Vascular, Santa Clara, California) for mitral regurgitation (MR) in the United States. OBJECTIVES The purpose of this study was to report 12-month outcomes in high-risk patients treated with the percutaneous mitral valve edge-to-edge repair. METHODS Patients with grades 3 to 4+ MR and a surgical mortality risk of ≥12%, based on the Society of Thoracic Surgeons risk calculator or the estimate of a surgeon coinvestigator following pre-specified protocol criteria, were enrolled. RESULTS In the studies, 327 of 351 patients completed 12 months of follow-up. Patients were elderly (76 ± 11 years of age), with 70% having functional MR and 60% having prior cardiac surgery. The mitral valve device reduced MR to ≤2+ in 86% of patients at discharge (n = 325; p < 0.0001). Major adverse events at 30 days included death in 4.8%, myocardial infarction in 1.1%, and stroke in 2.6%. At 12 months, MR was ≤2+ in 84% of patients (n = 225; p < 0.0001). From baseline to 12 months, left ventricular (LV) end-diastolic volume improved from 161 ± 56 ml to 143 ± 53 ml (n = 203; p < 0.0001) and LV end-systolic volume improved from 87 ± 47 ml to 79 ± 44 ml (n = 202; p < 0.0001). New York Heart Association functional class improved from 82% in class III/IV at baseline to 83% in class I/II at 12 months (n = 234; p < 0.0001). The 36-item Short Form Health Survey physical and mental quality-of-life scores improved from baseline to 12 months (n = 191; p < 0.0001). Annual hospitalization rate for heart failure fell from 0.79% pre-procedure to 0.41% post-procedure (n = 338; p < 0.0001). Kaplan-Meier survival estimate at 12 months was 77.2%. CONCLUSIONS The percutaneous mitral valve device significantly reduced MR, improved clinical symptoms, and decreased LV dimensions at 12 months in this high-surgical-risk cohort. (Endovascular Valve Edge-to-Edge REpair STudy [EVERESTIIRCT]; NCT00209274).

Randomized Comparison of Percutaneous Repair and Surgery for Mitral Regurgitation: 5-Year Results of EVEREST II.

BACKGROUND In EVEREST II (Endovascular Valve Edge-to-Edge Repair Study), treatment of mitral regurgitation (MR) with a novel percutaneous device showed superior safety compared with surgery, but less effective reduction in MR at 1 year. OBJECTIVES This study sought to evaluate the final 5-year clinical outcomes and durability of percutaneous mitral valve (MV) repair with the MitraClip device compared with conventional MV surgery. METHODS Patients with grade 3+ or 4+ MR were randomly assigned to percutaneous repair with the device or conventional MV surgery in a 2:1 ratio (178:80). Patients prospectively consented to 5 years of follow-up. RESULTS At 5 years, the rate of the composite endpoint of freedom from death, surgery, or 3+ or 4+ MR in the as-treated population was 44.2% versus 64.3% in the percutaneous repair and surgical groups, respectively (p = 0.01). The difference was driven by increased rates of 3+ to 4+ MR (12.3% vs. 1.8%; p = 0.02) and surgery (27.9% vs. 8.9%; p = 0.003) with percutaneous repair. After percutaneous repair, 78% of surgeries occurred within the first 6 months. Beyond 6 months, rates of surgery and moderate-to-severe MR were comparable between groups. Five-year mortality rates were 20.8% and 26.8% (p = 0.4) for percutaneous repair and surgery, respectively. In multivariable analysis, treatment strategy was not associated with survival. CONCLUSIONS Patients treated with percutaneous repair more commonly required surgery for residual MR during the first year after treatment, but between 1- and 5-year follow-up, comparably low rates of surgery for MV dysfunction with either percutaneous or surgical therapy endorse the durability of MR reduction with both repair techniques. (EVEREST II Pivotal Study High Risk Registry; NCT00209274).

Improved Functional Status and Quality of Life in Prohibitive Surgical Risk Patients With Degenerative Mitral Regurgitation After Transcatheter Mitral Valve Repair

BACKGROUND Surgical mitral valve repair (SMVR) remains the gold standard for severe degenerative mitral regurgitation (DMR). However, the results with transcatheter mitral valve repair (TMVR) in prohibitive-risk DMR patients have not been previously reported. OBJECTIVES This study aimed to evaluate treatment of mitral regurgitation (MR) in patients with severe DMR at prohibitive surgical risk undergoing TMVR. METHODS A prohibitive-risk DMR cohort was identified by a multidisciplinary heart team that retrospectively evaluated high-risk DMR patients enrolled in the EVEREST (Endovascular Valve Edge-to-Edge Repair Study) II studies. RESULTS A total of 141 high-risk DMR patients were consecutively enrolled; 127 of these patients were retrospectively identified as meeting the definition of prohibitive risk and had 1-year follow-up (median: 1.47 years) available. Patients were elderly (mean age: 82.4 years), severely symptomatic (87% New York Heart Association class III/IV), and at prohibitive surgical risk (STS score: 13.2 ± 7.3%). TMVR (MitraClip) was successfully performed in 95.3%; hospital stay was 2.9 ± 3.1 days. Major adverse events at 30 days included death in 6.3%, myocardial infarction in 0.8%, and stroke in 2.4%. Through 1 year, there were a total of 30 deaths (23.6%), with no survival difference between patients discharged with MR ≤1+ or MR 2+. At 1 year, the majority of surviving patients (82.9%) remained MR ≤2+ at 1 year, and 86.9% were in New York Heart Association functional class I or II. Left ventricular end-diastolic volume decreased (from 125.1 ± 40.1 ml to 108.5 ± 37.9 ml; p < 0.0001 [n = 69 survivors with paired data]). SF-36 quality-of-life scores improved and hospitalizations for heart failure were reduced in patients whose MR was reduced. CONCLUSIONS TMVR in prohibitive surgical risk patients is associated with safety and good clinical outcomes, including decreases in rehospitalization, functional improvements, and favorable ventricular remodeling, at 1 year. (Real World Expanded Multi-center Study of the MitraClip System [REALISM]; NCT01931956).

Initial Experience With Commercial Transcatheter Mitral Valve Repair in the United States.

BACKGROUND Transcatheter mitral valve (MV) repair with the MitraClip received approval in 2013 for the treatment of prohibitive-risk patients with primary mitral regurgitation (MR). OBJECTIVES The aim of this study was to report the initial U.S. commercial experience with transcatheter MV repair. METHODS Data from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry on patients commercially treated with this percutaneous mitral valve repair device were analyzed. RESULTS Of 564 patients (56% men, median age 83 years), severe symptoms were present in 473 (86.0%). The median Society of Thoracic Surgeons Predicted Risk of Mortality scores for MV repair and replacement were 7.9% (interquartile range: 4.7% to 12.2%) and 10.0% (interquartile range: 6.3% to 14.5%), respectively. Frailty was noted in 323 patients (57.3%). Transcatheter MV repair was performed for degenerative disease, present in 90.8% of patients. Overall, MR was reduced to grade ≤2 in 93.0%. In-hospital mortality was 2.3%; 30-day mortality was 5.8%. Other 30-day events were stroke (1.8%), bleeding (2.6%), and device-related complications (1.4%). The median length of stay was 3 days (interquartile range: 1 to 6 days), with 84.0% patients discharged home. Overall, procedure success occurred in 90.6%. Variables associated with reduction in MR were end-diastolic dimension, MR severity, clip location, and case volume. CONCLUSIONS In this study of the initial commercial U.S. experience, it was found that procedural success was achieved in approximately 91% of patients, and the majority of patients were discharged home with moderate or less MR. These data support the effectiveness of this therapy in appropriately selected high-risk patients in a commercial setting. Further study is required to determine the long-term impact of transcatheter MV repair in this patient population.

EVEREST II randomized clinical trial: Predictors of mitral valve replacement in de novo surgery or after the MitraClip procedure

OBJECTIVE The Endovascular Valve Edge-to-Edge Repair Study (EVEREST II) is a prospective, multicenter, randomized controlled trial comparing percutaneous repair with the MitraClip device to mitral valve (MV) surgery in the treatment of mitral regurgitation. The present study analyzed the patient characteristics and treatment effects on mitral repair versus replacement. METHODS Of 279 patients enrolled, 80 surgical patients underwent 82 MV operations and 178 underwent an initial MitraClip procedure, of whom 37 underwent a subsequent MV operation within 1 year of their index the MitraClip procedure. A logistic regression model was used to predict MV replacement according to valve pathology, etiology of mitral regurgitation, age, previous cardiac surgery, and treatment group. RESULTS The rate of percutaneous or surgical MV repair at 1 year was 89% (158/178) in patients initially receiving the MitraClip device versus 84% (67/80) in the surgical patients (P = .36). Surgical repair was performed after the MitraClip procedure in 20 (54%) of 37 patients (P < .001 vs surgery). In both the MitraClip device and surgery groups, MV replacement was significantly associated with anterior leaflet pathology (P = .035). Logistic regression analysis showed that anterior leaflet pathology predicted MV replacement. In 5 (13.5%) of 37 patients undergoing surgery after MitraClip therapy, replacement was performed in part because of MV injury associated with the MitraClip procedure. CONCLUSIONS These data suggest that anterior leaflet pathology is strongly associated with MV replacement in patients undergoing either de novo MV surgery or surgery after MitraClip therapy. MitraClip therapy has a repair rate similar to surgery through 1 year but also imparts a risk of replacement of a potentially repairable valve.

Efficacy and safety of ventricular tachycardia ablation with mechanical circulatory support compared with substrate-based ablation techniques

AIMS Catheter ablation of ventricular tachycardia (VT) can be limited by haemodynamic instability. In these cases, substrate-based ablation is typically performed. An alternative is to perform activation and entrainment mapping during VT supported by a percutaneous left ventricular assist device (pVAD). We sought to compare the complication and success rates of pVAD-assisted VT ablation with scar-based techniques. METHODS AND RESULTS Thirteen consecutive patients with haemodynamically unstable VT underwent pVAD-assisted ablation (pVAD group) and were retrospectively compared with 18-matched patients undergoing a substrate-based VT ablation (non-pVAD group). There was no significant difference in age or ejection fraction between the groups although pVAD patients tended to have more shocks in the preceding months. Procedure times were longer for the pVAD group. The number of monomorphic VTs induced was greater in the pVAD group (3.2 vs. 1.6, P= 0.04); however, after ablation, there was no difference in inducibility between the pVAD and non-pVAD group (10 of 13 vs. 12 of 18; 77 vs. 67%, P = 0.69). There was no difference in acute complications including stroke or death. At 9 ± 3 months, 1-year freedom from implantable cardioverter-defibrillator (ICD) shocks/therapies for sustained VT were similar (P= 0.96). In multivariable analysis, the absence of atrial fibrillation (hazard ratio=0.15, P= 0.04) was associated with a lower incidence of ICD shocks. CONCLUSIONS In high-risk patients, pVAD-assisted VT ablation guided by activation and entrainment mapping is a feasible alternative to substrate mapping and allows outcomes comparable to substrate mapping.

Assessment of Pulmonary Hypertension in the Pediatric Catheterization Laboratory: Current Insights From the Magic Registry

Objectives: To assess protocols, demographics, and hemodynamics in pediatric patients undergoing catheterization for pulmonary hypertension (PH). Background: Pediatric specific data is limited on PH. Methods: Review of the Mid‐Atlantic Group of Interventional Cardiology (MAGIC) collaboration PH registry dataset. Results: Between November 2003 and October 2008, seven institutions submitted data from 177 initial catheterizations in pediatric patients with suspected PH. Pulmonary arterial hypertension associated with congenital heart disease (APAH‐CHD) (n = 61, 34%) was more common than idiopathic PAH (IPAH) (n = 36, 20%). IPAH patients were older with higher mean pulmonary arterial pressures (mPAP) (P < 0.01). Oxygen lowered mPAP in patients with IPAH (P < 0.01) and associated PAH not related to congenital heart disease (APAH‐non CHD) (P < 0.01). A synergistic effect was seen with inhaled Nitric Oxide (iNO) (P < 0.01). Overall 9/30 (29%) patients with IPAH and 8/48 (16%) patients with APAH‐non CHD were reactive to vasodilator testing. Oxygen lowered pulmonary vascular resistance index (PVRI) in patients with APAH‐CHD (P < 0.01). There was no additive effect with iNO but a subset of patients required iNO to lower PVRI below 5 WU·m2. General anesthesia (GA) lowered systemic arterial pressure (P < 0.01) with no difference between GA and procedural sedation on mPAP or PVRI. Adverse events were rare (n = 7) with no procedural deaths. Conclusions: Pediatric patients with PH demonstrate a higher incidence of APAH‐CHD and neonatal specific disorders compared to adults. Pediatric PH patients may demonstrate baseline mPAP < 40 mm Hg but > 50% systemic illustrating the difficulty in applying adult criteria to children with PH. Catheterization in children with PH is relatively safe.

Percutaneous Mitral Valve Repair in the Initial EVEREST Cohort Evidence of Reverse Left Ventricular Remodeling

Background— Percutaneous repair of mitral regurgitation (MR) permits examination of the effect of MR reduction without surgery and cardiopulmonary bypass on left ventricular (LV) dimensions and function. The goal of this analysis was to determine the extent of reverse remodeling at 12 months after successful percutaneous reduction of MR with the MitraClip device. Methods and Results— Of 64 patients with 3 and 4+ MR who achieved acute procedural success after treatment with the MitraClip device, 49 patients had moderate or less MR at 12-month follow-up. Their baseline and 12-month echocardiograms were compared between the group with and without LV dysfunction. In patients with persistent MR reduction and pre-existing LV dysfunction, there was a reduction in LV wall stress, reduced LV end-diastolic volume, LV end-systolic volume and increase in LV ejection fraction in contrast to those with normal baseline LV function, who showed reduction in LV end-diastolic volume, LV wall stress, no change in LV end-systolic volume, and a fall in LV ejection fraction. Conclusions— Patients with pre-existing LV dysfunction demonstrate reverse remodeling and improved LV ejection fraction after percutaneous mitral valve repair. Clinical Trial Registration— URL: . Unique identifiers: [NCT00209339][1], [NCT00209274][2]. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT00209339&atom=%2Fcirccvim%2F6%2F4%2F522.atom [2]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT00209274&atom=%2Fcirccvim%2F6%2F4%2F522.atomBackground—Percutaneous repair of mitral regurgitation (MR) permits examination of the effect of MR reduction without surgery and cardiopulmonary bypass on left ventricular (LV) dimensions and function. The goal of this analysis was to determine the extent of reverse remodeling at 12 months after successful percutaneous reduction of MR with the MitraClip device. Methods and Results—Of 64 patients with 3 and 4+ MR who achieved acute procedural success after treatment with the MitraClip device, 49 patients had moderate or less MR at 12-month follow-up. Their baseline and 12-month echocardiograms were compared between the group with and without LV dysfunction. In patients with persistent MR reduction and pre-existing LV dysfunction, there was a reduction in LV wall stress, reduced LV end-diastolic volume, LV end-systolic volume and increase in LV ejection fraction in contrast to those with normal baseline LV function, who showed reduction in LV end-diastolic volume, LV wall stress, no change in LV end-systolic volume, and a fall in LV ejection fraction. Conclusions—Patients with pre-existing LV dysfunction demonstrate reverse remodeling and improved LV ejection fraction after percutaneous mitral valve repair. Clinical Trial Registration—URL: http://www.clinicaltrials.gov. Unique identifiers: NCT00209339, NCT00209274.

Percutaneous transthoracic ventricular puncture for diagnostic and interventional catheterization

Objective: To describe our experience in a case series of patients requiring percutaneous direct ventricular puncture and sheath placement for diagnosis or intervention. Background: Access to the right or left ventricle for percutaneous interventions is limited in patients with mechanical prostheses in either the tricuspid, or mitral and aortic positions. Methods: After coronary angiography, direct ventricular puncture under ultrasound and fluoroscopic guidance was performed. At end of case, protamine was given to reverse the heparin, and sheaths were pulled with purse‐string suture closure of the skin entrance. Results: For right ventricular access, 8‐ to 9‐F sheaths were placed from subxiphoid approach in 2 patients to allow conduit and pulmonary artery interventions. For left ventricular access in patients with mitral and aortic prostheses, 4‐ to 8‐F sheaths were placed from apical approach to allow diagnostic evaluation in 1 and interventions in 5 to occlude perivalvular mitral leaks and postoperative ventricular septal defect. Complication in one consisted of intercostal vein injury resulting in hemothorax requiring chest tube drainage. Conclusion: In this small cases series, direct ventricular puncture allowed the intervention to proceed with up to 9‐F sheath size. Attention to puncture site relative to intercostal vascular anatomy is warranted.