Direct Endoscopy-Guided Mitral Valve Repair in the Beating Heart An Acute Animal Study

Author(s):  
Tetsuya Horai ◽  
Kiyotaka Fukamachi ◽  
Hideyuki Fumoto ◽  
Tohru Takaseya ◽  
Akira Shiose ◽  
...  

Objective The purpose of this study was to develop a new method for minimally invasive mitral valve repair under direct endoscopic visualization in the beating heart. Methods Fiberoptic cardioscopy of the left heart was conducted in 12 calves. Systemic perfusion was maintained by cardiopulmonary bypass through a median sternotomy. A clear solution (Ringer's lactate) was temporarily administered via the pulmonary artery to flush out the pulmonary vasculature, and additional perfusion of the left heart chambers enhanced visualization of the intracardiac anatomy. The endoscope, with an open-ended transparent flexible outer sheath, was inserted through the left ventricular apex, and an endoscopic clip was used for edge-to-edge mitral valve repair. Hemodilution was avoided by the drainage of irrigation fluid via a left ventricular cannula. Results Direct endoscopic visualization of the mitral valve in an in vivo beating heart was obtained clearly, avoiding systemic hemodilution. In the last experiment, edge-to-edge repair using an endoscopic clip was successfully performed. Use of an effective intracardiac irrigation method was important for successful image acquisition and achievement of repair procedures. Conclusions This acute animal study showed the technical feasibility of beating-heart mitral valve surgery under direct endoscopic imaging. Although this study was performed under open-chest conditions, our successful experiment is a first step toward closed-chest intracardiac surgery with direct endoscopic visualization.

Author(s):  
Tetsuya Horai ◽  
Kiyotaka Fukamachi ◽  
Hideyuki Fumoto ◽  
Tohru Takaseya ◽  
Akira Shiose ◽  
...  

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
M Koschutnik ◽  
G Goliasch ◽  
C Nitsche ◽  
A.A Kammerlander ◽  
C Dona ◽  
...  

Abstract Background Implantable interatrial shunt devices improve pulmonary vascular function in patients with heart failure by transferring richly oxygenated blood to the right heart. Whether iatrogenic atrial septum defects (iASDs) after percutaneous edge-to-edge mitral valve repair (pMVR) are also associated with beneficial hemodynamic effects has not been investigated. Methods We consecutively enrolled patients with relevant functional (FMR) and degenerative mitral regurgitation (DMR) scheduled for pMVR. Invasive hemodynamic assessments were performed prior to and immediately after the procedure. Results 97 consecutive patients (75.4±9.1 years; 58% female) were prospectively included, 65 (66%) presented with relevant FMR. At baseline when compared to the DMR group, FMR was associated with worse left ventricular (LV) function (LV ejection fraction: 39 vs. 49%; p=0.001), higher NT-proBNP levels (7404 vs. 5214 pg/mL; p=0.023), worse renal function (serum creatinine: 1.7 vs. 1.3 mg/dL; p=0.019), and higher usage of spironolactone (68 vs. 42%; p=0.018) and sacubitril/valsartan (33 vs. 0%; p<0.001). Following pMVR, cardiac output (CO) and systemic blood flow (Qs) increased significantly (CO: 4.6 to 5.5 L/min; p<0.001; Qs: 4.9 to 5.8 L/min; p=0.002), with more pronounced changes in the FMR subgroup (ΔCO: 1.0 vs. 0.6 L/min; Figure 1A; ΔQs: 1.2 vs. 0.1 L/min), when compared to DMR. Pulmonary blood flow (Qp) increased by 26% (4.3 to 5.4 L/min; p=0.008), accompanied by a raise in pulmonary artery (PA) oxygen (O2) saturation from 73 to 77% (p<0.001). Arterial O2 saturation levels remained unchanged (98.3 to 98.7%; p=0.165), confirming no significant changes in systemic oxygenation. These changes were associated with a slight decline in pulmonary vascular resistance (PVR: 250 to 225 dynes*sec/cm5; p=0.369, Figure 1B), and a tendency towards improvement of pulmonary compliance (PAC: 3.6 to 4.0 mL/mmHg; p=0.414). Conclusions Invasively measured CO, Qs, Qp, and mixed-venous PA O2 saturation increased immediately after pMVR, alongside with potentially beneficial effects on pulmonary vasculature with marked improvements in PVR and PAC. These changes were more pronounced in the FMR subgroup. Further studies are required to assess long-term hemodynamic effects and underlying mechanisms of persistent iASDs on pulmonary vascular function. Figure 1. Invasive hemodynamics Funding Acknowledgement Type of funding source: None


2020 ◽  
Vol 59 (1) ◽  
pp. 199-206
Author(s):  
James S Gammie ◽  
Krzysztof Bartus ◽  
Andrzej Gackowski ◽  
Piotr Szymanski ◽  
Agata Bilewska ◽  
...  

Abstract OBJECTIVES The objective of this study was to evaluate the safety and performance of a novel, beating heart procedure that enables echocardiographic-guided beating heart implantation of expanded polytetrafluoroethylene (ePTFE) artificial cords on the posterior mitral leaflet of patients with degenerative mitral regurgitation. METHODS Two prospective multicentre studies enrolled 13 (first-in-human) and 52 subjects, respectively. Patients were treated with the HARPOON beating heart mitral valve repair system. The primary (30-day) end point was successful implantation of cord(s) with mitral regurgitation reduction to ≤moderate. An independent core laboratory analysed echocardiograms. RESULTS Of 65 patients enrolled, 62 (95%) achieved technical success, 2 patients required conversion to open surgery and 1 procedure was terminated. The primary end point was met in 59/65 (91%) patients. Among the 62 treated patients, the mean procedural time was 2.1 ± 0.5 h. Through discharge, there were no deaths, strokes or renal failure events. At 1 year, 2 of the 62 patients died (3%) and 8 (13%) others required reoperations. At 1 year, 98% of the patients with HARPOON cords were in New York Heart Association class I or II, and mitral regurgitation was none/trace in 52% (n = 27), mild in 23% (n = 12), moderate in 23% (n = 12) and severe in 2% (n = 1). Favourable cardiac remodelling outcomes at 1 year included decreased end-diastolic left ventricular volume (153 ± 41 to 119 ± 28 ml) and diameter (53 ± 5 to 47 ± 6 mm), and the mean transmitral gradient was 1.4 ± 0.7 mmHg. CONCLUSIONS This initial clinical experience with the HARPOON beating heart mitral valve repair system demonstrates encouraging early safety and performance. Clinical registration numbers NCT02432196 and NCT02768870.


2009 ◽  
Vol 137 (1) ◽  
pp. 188-193 ◽  
Author(s):  
Pietro Bajona ◽  
William E. Katz ◽  
Richard C. Daly ◽  
Kenton J. Zehr ◽  
Giovanni Speziali

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
T Benito Gonzalez ◽  
X Freixa ◽  
C Godino ◽  
M Taramasso ◽  
R Estevez-Loureiro ◽  
...  

Abstract Background Limited information has been reported regarding the impact of percutaneous mitral valve repair (PMVR) on ventricular arrhythmic (VA) burden. The aim of this study was to address the incidence of VA and appropriate antitachycardia implantable cardiac defibrillator (ICD) therapies before and after PMVR. Methods We retrospectively analyzed all consecutive patients with heart failure with reduce left ventricular ejection fraction, functional mitral regurgitation grade 3+ or 4+ and an active ICD or cardiac resynchronizer who underwent PMVR in any of the eleven recruiting centers. Only patients with complete available device VA monitoring from one-year before to one year after PMVR were included. Baseline clinical and echocardiographic characteristics were collected before PMVR and at 12-months follow-up. Results 93 patients (68.2±10.9 years old, male 88.2%) were enrolled. PMVR was successfully performed in all patients and device success at discharge was 91.4%. At 12-months follow-up, we observed a significant reduction in mitral regurgitation severity, NT-proBNP and prevalence of severe pulmonary hypertension and severe kidney disease. Patients also referred a significant improvement in NYHA functional class and showed a non-significant trend to reserve left ventricular remodeling. After PMVR a significant decrease in the incidence of non-sustained ventricular tachycardia (VT) (5.0–17.8 vs 2.7–13.5, p=0.002), sustained VT or ventricular fibrillation (0.9–2.5 vs 0.5–2.9, p=0.012) and ICD antitachycardia therapies (2.5–12.0 vs 0.9–5.0, p=0.033) were observed. Conclusion PMVR was related to a reduction in arrhythmic burden and ICD therapies in our cohort. Proportion of patients who presented ven Funding Acknowledgement Type of funding source: None


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
R Kavsur ◽  
C Iliadis ◽  
C Metze ◽  
M Spieker ◽  
V Tiyerili ◽  
...  

Abstract Background Recent studies indicate that careful patient selection is key for the percutaneous edge-to-edge repair via MitraClip procedure. The MIDA Score represents a useful tool for patient selection and is validated in patients with degenerative mitral regurgitation (MR). Aim We here assessed the potential benefit of the MIDA Score for patients with functional or degenerative MR undergoing edge-to-edge mitral valve repair via the MitraClip procedure. Methods In the present study, we retrospectively included 520 patients from three Heart Centers undergoing MitraClip implantation for MR. All parameters of the MIDA Score were available in these patients, consisting of the 7 variables age, symptoms, atrial fibrillation, left atrial diameter, right ventricular systolic pressure, left-ventricular end-systolic diameter, left ventricular ejection fraction. According to the median MIDA-Score of 9 points, patients were stratified in to a high and a low MIDA Score group and association with all-cause mortality was evaluated. Moreover, MR was assessed in echocardiographic controls in 370 patients at discharge, 279 patients at 3-months and 222 patients at 12 months after MitraClip implantation. Results During 2-years follow-up after MitraClip implantation, 69 of 291 (24%) patients with a high MIDA Score and 25 of 229 (11%) patients with a low MIDA Score died. Kaplan-Meier analysis and log rank test showed inferior rates of death in patients with a low score (p<0.001) and multivariate cox regression revealed an odds ratio of 0.54 (0.31–0.95; p=0.032) regarding 2-year survival in this group. Moreover, one point increase in the MIDA Score was associated with a 1.18-fold increase in the risk for mortality (1.02–1.36; p=0.025). Comparing patients with a high MIDA Score and patients with a low score, post-procedural residual moderate/severe MR tended to be more frequent in patients with a high MIDA Score at discharge (53% vs 43%; p=0.061), 3-months (50% vs 40%; p=0.091) and significantly at 12-months follow-up (52% vs 37%; p=0.029). Conclusion The MIDA Mortality Risk Score remained its predictive ability in patients with degenerative or function MR undergoing transcatheter edge-to-edge mitral valve repair. Moreover, a high MIDA score was associated with a higher frequency of post-procedural residual moderate/severe MR, indicating a lower effectiveness of this procedure in these patients. Funding Acknowledgement Type of funding source: None


Author(s):  
Leonardo Italia ◽  
Marianna Adamo ◽  
Laura Lupi ◽  
Marta Scodro ◽  
Salvatore Curello ◽  
...  

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