Percutaneous MitraClip Device or Surgical Mitral Valve Repair in Patients With Primary Mitral Regurgitation Who Are Candidates for Surgery: Design and Rationale of the REPAIR MR Trial.

Background The current standard of care for the treatment of patients with primary mitral regurgitation (MR) is surgical mitral valve repair. Transcatheter edge-to-edge repair with the MitraClip device provides a less invasive treatment option for patients with both primary and secondary MR. Worldwide, >150 000 patients have been treated with the MitraClip device. However, in the United States, MitraClip is approved for use only in primary patients with MR who are at high or prohibitive risk for mitral valve surgery. The REPAIR MR (Percutaneous MitraClip Device or Surgical Mitral Valve Repair in Patients With Primary Mitral Regurgitation Who Are Candidates for Surgery) trial is designed to compare early and late outcomes associated with transcatheter edge-to-edge repair with the MitraClip and surgical repair of primary MR in older or moderate surgical risk patients. Methods and Results The REPAIR MR trial is a prospective, randomized, parallel-controlled, open-label multicenter, noninferiority trial for the treatment of severe primary MR (verified by an independent echocardiographic core laboratory). Patients with severe MR and indications for surgery because of symptoms (New York Heart Association class II-IV), or without symptoms with left ventricular ejection fraction ≤60%, pulmonary artery systolic pressure >50 mm Hg, or left ventricular end-systolic diameter ≥40 mm are eligible for the trial provided they meet the moderate surgical risk criteria as follows: (1) ≥75 years of age, or (2) if <75 years of age, then the subject has a Society of Thoracic Surgeons Predicted Risk Of Mortality score of ≥2% for mitral repair (or Society of Thoracic Surgeons replacement score of ≥4%), or the presence of a comorbidity that may introduce a surgery-specific risk. The local surgeon must determine that the mitral valve can be surgically repaired. Additionally, an independent eligibility committee will confirm that the MR can be reduced to mild or less with both the MitraClip and surgical mitral valve repair with a high degree of certainty. A total of 500 eligible subjects will be randomized in a 1:1 ratio to receive the MitraClip device or to undergo surgical mitral valve repair (control group). There are 2 co-primary end points for the trial, both of which will be evaluated at 2 years. Each subject will be followed for 10 years after enrollment. The study has received approval from both the Food and Drug Administration and the Centers for Medicare and Medicaid Services, and enrolled its first subject in July 2020. Conclusions The REPAIR MR trial will determine the safety and effectiveness of transcatheter edge-to-edge repair with the MitraClip in patients with primary MR who are at moderate surgical risk and are candidates for surgical MV repair. The trial will generate contemporary comparative clinical evidence for the MitraClip device and surgical MV repair. Registration https://clinicaltrials.gov/ct2/show/NCT04198870; NCT04198870.

Radiologic assessment of HeartMate II position: Minimal pump migration after long-term support.

BACKGROUND: Surgical positioning of the HeartMate II (HMII) left ventricular assist device assuring an unobstructed blood flow path is essential for optimal device function and hemodynamic support. We report a non-invasive radiologic assessment of HMII position after implant and long-term follow-up. METHODS: We reviewed 132 consecutive patients (age 64 ± 14 years; 86% male; 60% destination therapy) implanted with an HMII from January 2009 to December 2012 and followed for them for up to 4 years. A radiologist measured pump position, pocket depth and cannula angles using chest radiography. Changes over time were determined in 64 of these patients with pairs of radiographs immediately after implant and at an average of 2.0 ± 0.7 years of follow-up. RESULTS: The axis of the pump relative to the spine was 92 ± 10° at baseline and 94 ± 9° at 2 years (n = 64, p = 0.02), and inflow cannula angles averaged 21 ± 13° from vertical at baseline and 20 ± 12° at 2 years (p = not statistically significant). More than 90% of angle measurements showed <15° movement over the follow-up duration. There was a small but significant superior pump migration from a depth of 12.7 ± 2.7 cm to 10.4 ± 2.6 cm (p < 0.001). There were no cannula obstructions or instances of right ventricular assist device use. The 30-day operative mortality was 3.0%. Prolonged inotrope dependence occurred in 5.3% (7 of 126) of patients, and low rates of pump thrombosis of 0.018 event/patient-year (0 at 3 months) and stroke 0.074 event/patient-year were noted. CONCLUSION: Non-invasive radiographic measurements of surgical pump placement designed to avoid pump and cannula malposition demonstrate stable position with minimal pump migration.

Pre-operative health status and outcomes after continuous-flow left ventricular assist device implantation.

BACKGROUND: Health status predicts adverse outcomes in heart failure and cardiac surgery patients, but its prognostic value in left ventricular assist device (LVAD) placement is unknown. METHODS: We examined the association of pre-operative health status, as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ), with survival and hospitalization after LVAD using the KCCQ score as a continuous variable and stratified by KCCQ score quartile plus missing KCCQ in 1,125 clinical trial participants who received the HeartMate II (Thoratec Corp, Pleasanton, CA) as destination therapy (n = 635) or bridge to transplantation (n = 490). RESULTS: The mean pre-operative KCCQ score was 29.4 ± 18.7 among survivors (n = 719), and 27.1 ± 18.3 (n = 406) in those who died. In time-to-event analysis for all available follow-up using health status as a continuous variable, the pre-operative KCCQ score did not correlate with overall mortality after LVAD implantation (p = 0.178). Small absolute differences were seen between the pre-operative KCCQ quartile and 30-day survival (Q4 95% vs. Q1 89% vs. missing 87%; p = 0.0009 for trend), 180-day survival (Q4 83% vs. Q1 76% vs missing 79%; p = 0.060 for trend), and days hospitalized at 180 days (Q4 29.8 ± 25.6 vs. Q1 34.1 ± 27.1 vs. missing 36.5 ± 29.9 days; p = 0.009 for trend). CONCLUSION: Our findings suggest that pre-operative health status has limited association with outcomes after LVAD implantation. Although these data require further study in a diverse population, mechanical circulatory support may represent a relatively unique clinical situation, distinct from heart failure and other cardiac surgeries, in which heart failure-specific health status measures may be largely reversed.

Risk assessment for continuous flow left ventricular assist devices: does the destination therapy risk score work? An analysis of over 1,000 patients.

OBJECTIVES: This study sought to assess the utility of the Destination Therapy Risk Score (DTRS) in patients with continuous flow left ventricular assist devices (LVAD). BACKGROUND: The DTRS was developed to predict the risk of 90-day in-hospital mortality with pulsatile flow LVAD as destination therapy (DT). Despite ongoing use in patients with continuous flow devices, its utility has not been studied in such populations. METHODS: The DTRS was determined in 1,124 patients with the continuous flow HeartMate II (Thoratec Corporation, Pleasanton, California) LVAD as a bridge to transplant (BTT, n = 486) and DT (n = 638) and 114 DT patients with the pulsatile flow HeartMate XVE (Thoratec Corporation). Patients were divided into risk groups based on DTRS: low (0-8), medium (9-16), and high (>16). RESULTS: The 90-day in-hospital mortality for low-, medium-, and high-risk groups was 8%, 7%, and 16%, respectively, for BTT patients; 9%, 12%, and 19%, respectively, for DT patients; and 11%, 18%, and 25%, respectively, for XVE DT patients. The high-risk groups had more than a 2-fold increased risk of mortality compared with the low-risk groups. However, the area under the receiver-operating characteristic curve for 90-day in-hospital mortality yielded modest values ranging from 0.54 to 0.58 for the HeartMate II BTT and DT groups, respectively. Survival rates over 2 years were statistically significantly different as stratified by the 3 DTRS groups for patients implanted for DT but not for BTT. CONCLUSIONS: DTRS provides poor discrimination of mortality for BTT patients and only modest discrimination for DT patients receiving continuous flow LVAD.