Outcome of medical therapy, repeat intervention, and mitral valve surgery after failed MitraClip therapy.

OBJECTIVES: Optimal treatment for residual mitral regurgitation (MR) after MitraClip failure is not clearly defined. We report our clinical experience and discuss treatment options. METHODS: Between January 2013 and January 2018, 37 patients (75 ± 8.9 years, 46% male) were admitted for symptomatic MR (grade 3.1 ± 0.47) diagnosed after previous MitraClip therapy. Clinical outcome of these patients, who underwent medical therapy alone (n = 8, M-group), repeat MitraClip therapy (n = 8, reMC group), or mitral valve surgery (n = 21, S-group) for residual MR, were retrospectively analyzed. RESULTS: Thirty-day survival was 88% (M-group), 100% (reMC-group), and 76% (S-group). The rate of discharge to home was 88% in the reMC-group, better than 38% in the M-group (p = 0.051) and 19% in the S-group (p < 0.001). Perioperative non-survivors in the S-group had high surgical risk with median logistic EuroSCORE of 64.6% (interquartile range 57.4%-87.0%); all died from low cardiac output syndrome or multiple organ failure. The main MR pathologies resulted from leaflet tear and tethering in the M-group, tethering in the reMC-group, and degenerative valve and leaflet tear in the S-group. Kaplan-Meier analysis of overall survival at 1 year showed better outcome for patients in the reMC-group (50%, 95% CI 15.2-77.5%) and S-group (47.6%, 95% CI 25.7-66.7%), as compared to those in the M-group (12.5%, 95% CI 0.70-42.3%) (log-rank test p = 0.108 and p = 0.167, respectively). CONCLUSION: Medical therapy alone after failed MitraClip therapy resulted in poor 1-year prognosis. In patients without extremely high surgical risk, repeat MitraClip therapy, or surgical revision MIGHT BE CONSIDERED depending on valve pathology and cardiac comorbidities.

Outcome comparison of mitral valve surgery and MitraClip therapy in patients with severely reduced left ventricular dysfunction.

AIMS: The aim of this study was to compare the outcomes of surgical mitral valve repair or replacement (sMVR) and percutaneous edge-to-edge repair using MitraClip (pMVR) in patients with severe left ventricular dysfunction affected by functional mitral regurgitation (FMR). METHODS AND RESULTS: We retrospectively identified 132 patients with left ventricular ejection fraction (LVEF) â‰¦ 30% submitted to sMVR (n = 47) or pMVR (n = 85) for FMR at our centre from January 2013 to December 2017. To adjust for baseline imbalances, we used a propensity score matching by age, logistic EuroSCORE, and left ventricular end-systolic volume. After being matched, MitraClip therapy showed lower perioperative mortality and rate of complications yet increased residual mitral regurgitation (MR) grade than did surgery (0.2 ± 0.50 in sMVR vs. 1.3 ± 0.88 in pMVR, P < 0.0001). According to stratified multivariate Cox model analysis, residual MR severity was an independent risk factor for cardiac death [hazard ratio (HR), 2.81; 95% confidence interval [CI], 1.44-5.48, P = 0.0025] and re-hospitalization for heart failure (HR, 3.07; 95% CI, 1.50-6.29, P = 0.0022) at 1 year follow-up. Stratified multivariable Cox regression analysis at 3 years identified pMVR as risk factor for cardiac death (HR, 0.19; 95% CI, 0.040-0.86, P = 0.031) and re-hospitalization for heart failure (HR, 0.28; 95% CI, 0.077-0.99, P = 0.048). CONCLUSIONS: In patients with FMR and LVEF ≤ 30%, MitraClip therapy resulted in lower perioperative complications and mortality than sMVR. However, surgically treated patients who survived the perioperative stage had less residual MR and experienced lower rates of re-hospitalization for heart failure at 1 year and lower cardiac mortality at 1 and 3 years of follow-up than did patients undergoing pMVR.

Impact of preinterventional tricuspid regurgitation on outcome of MitraClip therapy in patients with severely reduced ejection fraction.

Aim: To evaluate the impact of preinterventional moderate-to-severe functional tricuspid regurgitation (FTR) on early outcome after percutaneous edge-to-edge mitral valve repair (pMVR) with MitraClip procedures for functional mitral regurgitation (FMR) in patients with heart failure with reduced ejection fraction (HFrEF). Methods and results: From January 2013 to December 2017, 80 patients with HFrEF (ejection fraction 22%±5.3%) and FMR (grade 3.0±0.36) underwent successful pMVR. The 3-year actuarial survival was 58%. However, 73% (n=22) of non-survivors died of cardiac failure within 1 year. Patients were categorised into none-to-mild (n=36) and moderate-to-severe (n=44) postinterventional FTR groups according to pre-MitraClip tricuspid regurgitation grade. Cox regression analysis on 1-year survival demonstrated an impact of FTR severity (HR=1.8, 95% CI 1.01% to 3.09%, p=0.047), preoperative New York Heart Association class (HR=2.8, 95% CI 1.2% to 6.5%, p=0.015) and peripheral artery disease (HR=5.4, 95% CI 1.6 to 18, p=0.0054). Kaplan-Meier analysis showed that 1-year cardiac death was higher in the moderate-to-severe FTR group (p=0.048). In our study, 77% of pre-MitraClip moderate-to-severe FTR cannot be significantly reduced. Post-MitraClip moderate-to-severe FTR grade was related to lower survival (p<0.001). Conclusion: In patients with HFrEF treated with MitraClip for FMR, moderate-to-severe FTR was an independent predictor of cardiac death within 1 year. To improve survival, additional therapy to residual FTR should be considered in early phase after MitraClip therapy.

Femoral transcatheter valve-in-valve implantation as alternative strategy for failed aortic bioprostheses: A single-centre experience with long-term follow-up.

BACKGROUND: Surgical reoperation is still a standard procedure performed for degenerated aortic bioprostheses. On the other hand femoral minimally invasive valve-in-valve implantation (femTAVI-VIV) is an intriguing alternative. This clinical study was design to compare the early and late outcomes of redo-surgery (Redo-AVR) and femTAVI-VIV procedures for failed aortic bioprostheses. METHODS: We retrospectively reviewed 108 patients with degenerated aortic bioprostheses qualified for isolated Redo-AVR (n = 40) or femTAVI-VIV (n = 68) between 2003 and 2018. Both cohorts were divided into intermediate and high-risk groups according to the EuroSCORE II (4-9% and >9%). Propensity score matching selected 20 pairs in Intermediate-risk group and 10 pairs in High-risk group for the final comparison. RESULTS: Patients qualified for femTAVI-VIV were older (79.2 vs 72.9 years, p < 0.001) and at higher risk (EuroSCORE II 10.9 vs 7.8%, p = 0.005) than Redo-AVR subjects. Overall survival in femTAVI-VIV and Redo-AVR was comparable at 30-days, 1- and 5-years, respectively (92.6% vs 92.5%, 85.2% vs 85.0% and 62.9% vs 72.5%, p = 0.287). After PSM no differences in mortality, myocardial infarction, pacemaker implantation, stroke or acute renal insufficiency were found. Transcatheter procedure was associated with shorter hospital stay, lower rate of blood products transfusions and higher incidence of mild paravalvular leaks. CONCLUSION: Our study supports the opinion that transcatheter approach for treatment of patients with degenerated aortic bioprostheses is a safe alternative to Redo-AVR procedures particularly for those at high-risk.

Surgical revision of failed percutaneous edge-to-edge mitral valve repair: lessons learned.

OBJECTIVES: Although percutaneous edge-to-edge mitral valve repair with the MitraClip system is becoming widely adopted in clinical practice, surgical experience on how to correct failed MitraClip therapy is limited. We aimed to analyse the surgical and pathological outcomes after surgical revision of the failed MitraClip therapy. METHODS: Between January 2011 and January 2018, 25 patients (age 73 ± 9 years; men 48%; New York Heart Association class 3.4 ± 0.49) were admitted for severe mitral regurgitation at a median of 54 days (range 1-1496 days) after MitraClip edge-to-edge repair. Perioperative variables were analysed for their association with surgical outcomes. RESULTS: All patients underwent explantation of the MitraClip system and subsequent mitral valve replacement. Perioperative mortality was as high as 28%, mainly due to pre-existing cardiogenic or septic shock. The Kaplan-Meier analysis revealed a 53% overall 1-year survival. Among preoperative variables, the logistic European System for Cardiac Operative Risk Evaluation score, left ventricular ejection fraction and liver dysfunction had a significant influence on in-hospital survival. Intraoperatively, the predominant pathology included mitral valve leaflet damage due to tear, degeneration or infection. Although leaflet tears or MitraClip detachment mainly occurred within the first 6 months after MitraClip therapy, leaflet infections and degeneration mainly occurred later during follow-up. CONCLUSIONS: The surgical revision of failed MitraClip therapy is feasible but has high perioperative mortality, especially among patients with cardiogenic shock, septic shock or liver failure. Mitral regurgitation after the MitraClip therapy is mainly caused by mitral valve leaflet damage due to tear, degeneration or infection, all related to the MitraClip itself.

Surgical repair of an uncontrolled thrombus caused by the Watchman device.

A device-related thrombus is a very common complication after the implantation of a Watchman device. Although anticoagulation therapy is the standard first choice therapy for a device-related thrombus, complications related to bleeding or existence of non-responders to the anticoagulation therapy are reported. Therefore, the possibility of another treatment, including surgical repair, needs to be discussed in the population unsuccessfully treated with anticoagulation therapy. We performed device-related thrombus removal and covered the orifice of the left atrial appendage with an autologous pericardial patch in 2 cases involving non-responders to anticoagulation therapy. Herein, we describe the technique and results of our experience with these 2 patients. The covering technique with an autologous pericardial patch is simple but highly efficient in preventing recurrent thrombus formation.

Acoustic phenomena and valve dysfunction in cardiac prostheses: data acquisition and collection via the Internet.

BACKGROUND AND AIM OF THE STUDY: The study aim was to investigate whether: (i) by detection of changing acoustic sound phenomena, minimal changes in prosthetic valve function may be detected earlier than with echocardiography, invasive diagnosis or clinically; (ii) patients can record and pass on signals with a high level of reproducibility from any location via the Internet; and (iii) clinical data evaluation permits conclusions to be drawn on changes in the functional state of a prosthetic replacement valve. METHODS: Simulation studies were carried out using a mock circulation device. Aortic valve replacement (AVR) using extracorporeal circulation was performed in pigs, valve function was artificially disturbed, and valve sounds were recorded. Patients were equipped with briefcase-like devices to record their valve sounds after AVR and to transfer them via the Internet. RESULTS: Simulation studies produced a typical sound spectrum for each tested valve that remained constant under variable conditions. Experiments in animals proved that minimal changes in prosthetic valve function led to a significant change in the sound phenomena. The degree of sensitivity was significantly greater than that in echocardiographic control experiments. All patients in the clinical study regularly recorded and passed on their signals. Surveys revealed high acceptance and easy handling of the compiled devices. Valve dysfunctions were not detected. CONCLUSION: On-line registration of acoustic sound phenomena and ECG seems suited to detect minimal changes in prosthetic function. In particular, the registration of flow, acoustics and ECG envisaged at the next level opens up diverse potential applications for Internet-based, remote monitoring of patients following cardiac surgery or cardiologic treatment.