Incidence, characteristics, and outcomes of reintervention after mitral transcatheter edge-to-edge repair.

OBJECTIVE: The use of transcatheter edge-to-edge repair (TEER) is growing substantially, and reintervention after TEER by way of repeat TEER or mitral valve surgery (MVS) is increasing as a result. In this nationally representative study we examined the incidence, characteristics, and outcomes of reintervention after index TEER. METHODS: Between July 2013 and November 2017, we reviewed 11,396 patients who underwent index TEER using Medicare beneficiary data. These patients were prospectively tracked and identified as having repeat TEER or MVS. Primary outcomes included 30-day mortality, 30-day readmission, 30-day composite morbidity, and cumulative survival. RESULTS: Among 11,396 patients who underwent TEER, 548 patients (4.8%) required reintervention after a median time interval of 4.5 months. Overall 30-day mortality was 8.6%, 30-day readmission was 20.9%, and 30-day composite morbidity was 48.2%. According to reintervention type, 294 (53.7%) patients underwent repeat TEER, and 254 (46.3%) underwent MVS. Patients who underwent MVS were more likely to be younger and female, but had a similar comorbidity burden compared with the repeat TEER cohort. After adjustment, there were no differences in 30-day mortality (adjusted odds ratio [AOR], 1.26 [95% CI, 0.65-2.45]) or 30-day readmission (AOR, 1.14 [95% CI, 0.72-1.81]). MVS was associated with higher 30-day morbidity (AOR, 4.76 [95% CI, 3.17-7.14]) compared with repeat TEER. Requirement for reintervention was an independent risk factor for long-term mortality in a Cox proportional hazard model (hazard ratio, 3.26 [95% CI, 2.53-4.20]). CONCLUSIONS: Reintervention after index TEER is a high-risk procedure that carries a significant mortality burden. This highlights the importance of ensuring procedural success for index TEER to avoid the morbidity of reintervention altogether.

Novel Multiphase Assessment for Predicting Left Ventricular Outflow Tract Obstruction Before Transcatheter Mitral Valve Replacement.

OBJECTIVES: This study proposes a physiologic assessment of left ventricular outflow tract obstruction (LVOTO) that accommodates changes in systolic flow and accounts for the dynamic neo-left ventricular outflow tract (LVOT). BACKGROUND: Patients considered for transcatheter mitral valve replacement trials often screen-fail because of the perceived risk of LVOTO. In the Intrepid Global Pilot Study, assumed risk of LVOTO was based on computed tomography estimates of the neo-LVOT area computed at end-systole. However, this may overestimate actual risk. METHODS: Retrospective analyses were performed for screen-failed patients for potential LVOTO (n = 33) and treated patients (n = 29) with available dynamic computed tomography. A multiphase assessment of the neo-LVOT area was performed and represented as: 1) multiphase average; and 2) early systolic value. Prospective evaluation was performed in 9 patients approved for enrollment with multiphase and early systole methods that would have previously screen-failed with the end-systolic approach. RESULTS: Of 166 patients screened for possible inclusion; 32 were screen-failed for nonanatomical reasons. Screen failure for assumed LVOTO risk occurred in 37 of 134 (27.6%) patients. Retrospective analysis indicated a potential enrollment increase of 11 of 33 (33.3%) and 18 of 33 (54.5%) patients using multiphase and early systolic assessment methods. In the prospective cohort, there were no clinical observations of LVOTO 30 days post-procedure, despite assumed risk based on end-systolic estimates. CONCLUSIONS: Multiphase, and specifically early systolic, assessment of the neo-LVOT may better determine risk of LVOTO with transcatheter mitral valve replacement compared with end-systolic estimates. This novel approach has the potential to significantly increase patient eligibility, with over one-half of patients previously screen-failed now eligible for treatment.

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.

Contemporary Costs Associated With Transcatheter Aortic Valve Replacement: A Propensity-Matched Cost Analysis.

BACKGROUND: The Placement of Aortic Transcatheter Valve (PARTNER) trial suggested an economic advantage for transcatheter aortic valve replacement (TAVR) for high-risk patients. The purpose of this study was to evaluate the cost effectiveness of TAVR in the "real world" by comparing TAVR with surgical aortic valve replacement (SAVR) in intermediate-risk and high-risk patients. METHODS: A multiinstitutional database of The Society of Thoracic Surgeons (STS) (2011 to 2013) linked with estimated cost data was evaluated for isolated TAVR and SAVR operations (n = 5,578). TAVR-treated patients (n = 340) were 1:1 propensity matched with SAVR-treated patients (n = 340). Patients undergoing SAVR were further stratified into intermediate-risk (SAVR-IR: predicted risk of mortality [PROM] 4% to 8%) and high-risk (SAVR-HR: PROM >8%) cohorts. RESULTS: Median STS PROM for TAVR was 6.32% compared with 6.30% for SAVR (SAVR-IR 4.6% and SAVR-HR 12.4%). A transfemoral TAVR approach was most common (61%). Mortality was higher for TAVR (10%) compared with SAVR (6%, p < 0.047), whereas the SAVR group accrued higher major morbidity (27% vs 14%, p < 0.001) and longer postoperative hospital duration (7 days vs 6 days, p < 0.001). Importantly, TAVR incurred twice the median total costs compared with SAVR ($69,921 vs $33,598, p < 0.001). The increased cost of TAVR was largely driven by the cost of the valve (all p < 0.001). Intermediate-risk patients undergoing SAVR demonstrated the most exaggerated cost savings versus TAVR. CONCLUSIONS: TAVR was associated with greater total costs and mortality compared with SAVR in intermediate-risk and high-risk patients while conferring lower major morbidity and improved resource use. Increased cost of TAVR appears largely related to the cost of the valve. Until the price of TAVR valves decreases, these data suggest that TAVR may not provide the most cost-effective strategy, particularly for intermediate-risk patients.

Cost-analysis of percutaneous pulmonary valve implantation compared to surgical pulmonary valve replacement.

OBJECTIVES: To perform cost evaluation and economic modeling of percutaneous pulmonary valve implantation (PPVI) compared to surgical revision. BACKGROUND: While, PPVI appears to be a viable alternative to surgical conduit revision in select patients with right ventricular outflow tract anomalies, its overall economic burden has yet to be determined. METHODS AND RESULTS: We examined the first 17 patients who underwent PPVI at our institution and compared them with the most-recently placed surgical valves. Economic data were obtained from the actual procedural and in-hospital charges and used as the base estimates for 5- and 10-year future modeling with appropriate sensitivity analysis. Median total hospital and procedural charges incurred by the patient were significantly higher for the surgical valve compared with PPVI ($126,406 ± $38,772 vs. $80,328 ± $17,387, P < 0.001). Median total societal charges were also higher for the surgical valve ($129,519 ± $39,021 vs. $80,939 ± $17,334, P < 0.001) owing to an average wage loss of $3,113 for surgical patients, contrasted to $611 who underwent PPVI, and a shorter length of stay (1.0 ± 0 vs. 5.7 ± 2.2, P <0.001) for PPVI. Sensitivity analysis determined that PPVI would need to fail at a rate of 17% per year (or 93% at 10 years) to lose its cost advantage. CONCLUSIONS: PPVI holds a significant cost advantage over the surgical approach, fewer hospital days, and incurs less patient wage loss. Furthermore, it would need to have a very high failure rate at 10 years to lose its cost advantage.

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·m(2). 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.