Robert Schueler

Transcatheter Treatment of Severe Tricuspid Regurgitation with the Edge-to-Edge: MitraClip Technique.

Background: Current surgical and medical treatment options for severe tricuspid regurgitation (TR) are limited, and additional interventional approaches are required. In the present observational study, the safety and feasibility of transcatheter repair of chronic severe TR with the MitraClip system were evaluated. In addition, the effects on clinical symptoms were assessed. Methods: Patients with heart failure symptoms and severe TR on optimal medical treatment were treated with the MitraClip system. Safety, defined as periprocedural adverse events such as death, myocardial infarction, stroke, or cardiac tamponade, and feasibility, defined as successful implantation of 1 or more MitraClip devices and reduction of TR by at least 1 grade, were evaluated before discharge and after 30 days. In addition, functional outcome, defined as changes in New York Heart Assocation class and 6-minute walking distance, were assessed. Results: We included 64 consecutive patients (mean age 76.6±10 years) deemed unsuitable for surgery who underwent MitraClip treatment for chronic, severe TR for compassionate use. Functional TR was present in 88%; in addition, 22 patients were also treated with the MitraClip system for mitral regurgitation as a combined procedure. The degree of TR was severe or massive in 88% of patients before the procedure. The MitraClip device was successfully implanted in the tricuspid valve in 97% of the cases. After the procedure, TR was reduced by at least 1 grade in 91% of the patients, thereof 4% that were reduced from massive to severe. In 13% of patients, TR remained severe after the procedure. Significant reductions in effective regurgitant orifice area (0.9±0.3cm2 versus 0.4±0.2cm2; P<0.001), vena contracta width (1.1±0.5 cm versus 0.6±0.3 cm; P=0.001), and regurgitant volume (57.2±12.8 mL/beat versus 30.8±6.9 mL/beat; P<0.001) were observed. No intraprocedural deaths, cardiac tamponade, emergency surgery, stroke, myocardial infarction, or major vascular complications occurred. Three (5%) in-hospital deaths occurred. New York Heart Association class was significantly improved (P<0.001), and 6-minute walking distance increased significantly (165.9±102.5 m versus 193.5±115.9 m; P=0.007). Conclusions: Transcatheter treatment of TR with the MitraClip system seems to be safe and feasible in this cohort of preselected patients. Initial efficacy analysis showed encouraging reduction of TR, which may potentially result in improved clinical outcomes.

Treatment of Chronic Functional Mitral Valve Regurgitation With a Percutaneous Annuloplasty System

BACKGROUNDnCurrent surgical and medical treatment options for functional mitral regurgitation (FMR) are limited and additional interventional approaches are required.nnnOBJECTIVESnThis study sought to report the safety and performance data from the feasibility study with a novel direct annuloplasty system.nnnMETHODSnSeventy-one patients with moderate to severe FMR (mean 67.7 ± 11.3 years of age, left ventricular [LV] ejection fraction 34.0 ± 8.3%), on stable medical heart failure medication were prospectively enrolled.nnnRESULTSnDevice success rate was 70.4% (nxa0= 50 of 71). No intraprocedural death occurred. In patients receiving implants, 4 patients (8.9%) experienced cardiac tamponade. Thirty-day (nxa0= 45) and 6-month (nxa0= 41) rates for all-cause mortality, stroke, and myocardial infarction were 4.4%, 4.4%, and 0.0% and 12.2%, 4.9%, and 0%, respectively. At 6xa0months, nonurgent mitral surgery was performed in 1 patient (2.4%) and nonurgent percutaneous repair in 7 patients (17.1%). Echocardiographic core analysis after 6 months showed mitral regurgitation reduction in 50% of treated patients by a mean of 1.3 grades. Concerning mitral valve (MV) annular geometry, we found significant reduction of anterior-posterior (-0.31 ± 0.4 cm) and septal-lateral dimensions (-0.21 ± 0.3 cm), a decreased MV-tenting area (-0.57 ± 1.1 cm(2)) and increase in MV coaptation length (0.13 ± 0.2 cm). Transthoracic echocardiography indicated reverse LV remodeling with reduction of LV end-diastolic diameter (-0.20 ± 0.4 mm) and volume (-22 ± 39 ml). Treatment was associated with significant improvement in 6-min walking distances (56.5 ± 92.0 m) and improvements in New York Heart Association functional class III/IV at 6 months from 53.3% to 23.3%.nnnCONCLUSIONSnPercutaneous direct annuloplasty is feasible and safe in high-risk FMR patients. This treatment initiates LV reverse remodeling, and provides clinical improvement during 6 months after treatment. (Mitralign Percutaneous Annuloplasty First in Man Study; NCT01852149).

Transcatheter Mitral Annuloplasty in Chronic Functional Mitral Regurgitation: 6-Month Results With the Cardioband Percutaneous Mitral Repair System.

OBJECTIVESnThis study sought to show safety and efficacy of the Cardioband system during 6 months after treatment.nnnBACKGROUNDnCurrent surgical and medical treatment options for functional mitral regurgitation (FMR) are limited. The Cardioband system (Valtech Cardio, OrYehuda, Israel) is a novel transvenous, transseptal direct annuloplasty device.nnnMETHODSnThirty-one patients (71.8 ± 6.9 years of age; 83.9% male; EuroSCORE II: 8.6 ± 5.9) with moderate to severe FMR, symptomatic heart failure, and depressed left ventricular function (left ventricular ejection fraction 34 ± 11%) were prospectively enrolled.nnnRESULTSnProcedural success rate, defined as delivery of the entire device, was 100%. There were no periprocedural deaths (0%), and mortality rate at 1 month or prior to hospital discharge and at 7 months was 5% and 9.7% respectively. Cinching of the implanted Cardioband reduced the annular septolateral dimension by >30% from 3.7 ± 0.5 cm at baseline to 2.5 ± 0.4xa0cm after 1 month and to 2.4 ± 0.4 cm after 6 months, respectively (pxa0< 0.001). Percentage of patients withxa0FMRxa0≥3 was reduced from 77.4% to 10.7% 1 month after the procedure (pxa0< 0.001) and 13.6% (pxa0< 0.001) at 7xa0months. Percentage of patients with New York Heart Association functional class III/IV decreased from 95.5% to 18.2%xa0after 7 months (pxa0< 0.001); exercise capacity as assessed by 6-min walking test increased from 250 ± 107 m to 332xa0±xa0118 m (pxa0< 0.001) and quality of life (Minnesota Living With Heart Failure Questionnaire) was also significantly improved (pxa0< 0.001).nnnCONCLUSIONSnIn this feasibility trial in symptomatic patients with FMR, transcatheter mitral annuloplasty with thexa0Cardioband was effective in reducing MR and was associated with improvement in heart failure symptoms andxa0demonstrated a favorable safety profile. (Cardioband With Transfemoral Delivery System; NCT01841554).

Acute Changes of Mitral Valve Geometry During Interventional Edge-to-Edge Repair With the MitraClip System Are Associated With Midterm Outcomes in Patients With Functional Valve Disease Preliminary Results From a Prospective Single-Center Study

Background—Transcatheter mitral valve repair (TMVR) is a treatment option in patients with symptomatic functional or degenerative mitral regurgitation (DMR) at high surgical risk. The acute effect of MitraClip procedure on mitral valve (MV) annular geometry and its relation to functional outcomes is unclear. We sought to assess immediate effect of TMVR on MV annular geometry with 3-dimensional (3D) transesophageal echocardiography and the association of MV diameter reduction with functional response after 6 months. Methods and Results—Consecutive patients (n=111; age, 78.3±8.1 years) at high surgical risk (logistic EuroSCORE [European System for Cardiac Operative Risk Evaluation], 29.8±21.5%) underwent TMVR. The procedure was completed successfully in 107 (96%) patients with 3D reconstruction of MV annular geometry immediately before and after clip implantation. Only patients with functional mitral regurgitation (n=71) experienced an acute reduction of anterior-posterior MV diameters (4.0±0.6 and 3.6±0.6 cm; P<0.0001), MV annulus areas (2D annulus area, 13.9±3.8 and 12.8±3.4 cm2; P<0.0001 and 3D annulus area, 14.4±3.9 and 12.9±3.4 cm2; P<0.0001), and MV annular geometry (MV sphericity index, 0.9±0.1 and 0.8±0.1; P<0.0001); the lateral medial MV diameters remained unchanged (4.3±0.7 and 4.4±0.6 cm; P=0.13). In subjects with DMR, all MV annular geometry-defining values were not significantly altered after TMVR (n=36; P>0.05). Acute anterior-posterior diameter reduction was associated with clinical response to TMVR after 6 months of follow-up (cutoff value, ≥6.4%; area under the curve, 0.81; P=0.002; sensitivity, 81.6%; specificity, 81.8%), which was confirmed by additional regression analysis (P=0.007). Conclusions—Three-dimensional transesophageal echocardiography enables assessment of acute changes of MV geometry in patients undergoing the MitraClip procedure. Only patients with functional mitral regurgitation experienced significant reduction of MV annular dimensions, which was associated with clinical response to TMVR.

Interventional Direct Annuloplasty for Functional Tricuspid Regurgitation

A 75-year-old man (European System for Cardiac Operative Risk Evaluation II 6.34%) presented with aggravating dyspnea New York Heart Association functional class III, edema, and fatigue despite best medical treatment. Three-dimensional transoesophageal echocardiography (TEE) showed massive tricuspid

Impact of left ventricular conduction defect with or without need for permanent right ventricular pacing on functional and clinical recovery after TAVR

BackgroundLeft ventricular conduction disturbances (VCD) with or without need for pacemaker (PM) implantation are common after transcatheter aortic valve replacement (TAVR). Its effect on patients’ functional recovery after TAVR is unclear.Methods and results212 patients (Age 80.8xa0±xa06.4xa0years, logEuroscore 28.95xa0±xa017.37xa0%) underwent TAVR with the self-expanding CoreValve prosthesis and completed 9-month follow-up (FU). After TAVR 125xa0(59xa0%) patients were diagnosed with VCD. This group consists of 41xa0(19xa0%) patients with a new PM after TAVR, 33xa0(16xa0%) patients with PM prior TAVR and markedly increased ventricular stimulation rate, 48xa0(23xa0%) patients with new LBBB post-TAVR and three (1xa0%) patients with LBBB prior TAVR. After FU, the presence of VCD alone was associated with worse recovery of left ventricular ejection fraction (LVEF) (VCD: LVEFbaseline 51.7xa0±xa018.2xa0%, LVEFFU 53.9xa0±xa013.0xa0%; pxa0=xa00.8; noVCD: LVEFbaseline 53.8xa0±xa012.9xa0%, LVEFFU 63.4xa0±xa010.1xa0%; pxa0<xa00.01) but had no impact on functional outcomes after TAVR (pxa0>xa00.05). Especially patients with VCD caused by permanent RV pacing showed worse functional outcomes presenting with higher functional NYHA classes (pxa0<xa00.05), and higher NT-proBNP levels (pxa0<xa00.05). 20.4xa0% of patients with need for PM after TAVR remained in NYHA class ≥3, as compared to 5xa0% of patients without PM (VCD but no PM: 4.7xa0%, pxa0<xa00.001; noVCD: 5.3xa0%, pxa0<xa00.001). VCD with or without need for PM had no impact on survival after FU.ConclusionThe occurrence of VCD after TAVR is common and associated with unfavorable left ventricular functional recovery. However, only the combination of VCD with permanent right ventricular pacing has adverse impact on heart failure-related symptoms after TAVR.

Compassionate use of the PASCAL transcatheter mitral valve repair system for patients with severe mitral regurgitation: a multicentre, prospective, observational, first-in-man study

BACKGROUNDnSevere mitral regurgitation is associated with impaired prognosis if left untreated. Using the devices currently available, transcatheter mitral valve repair (TMVr) remains challenging in complex anatomical situations. We report the procedural and 30-day results of the first-in-man study of the Edwards PASCAL TMVr system.nnnMETHODSnIn this multicentre, prospective, observational, first-in-man study, we collected data from seven tertiary care hospitals in five countries that had a compassionate use programme in which patients underwent transcatheter mitral valve repair using the Edwards PASCAL TMVr system. Eligible patients were those with symptomatic, severe functional, degenerative, or mixed mitral regurgitation deemed at high risk or inoperable. Safety and efficacy of the procedure were prospectively assessed at device implantation, discharge, and 30 days after device implantation. The key study endpoints were technical success assessed at the end of the procedure and device success 30 days after implantation using the Mitral Valve Academic Research Consortium definitions.nnnFINDINGSnBetween Sept 1, 2016, and March 31, 2017, 23 patients (median age 75 years [IQR 61-82]) had treatment for moderate-to-severe (grade 3+) or severe (grade 4+) mitral regurgitation using the Edwards PASCAL TMVr system. At baseline, the median EuroScore II score was 7·1% (IQR 3·6-12·8) and the median Society of Thoracic Surgeons predicted risk of mortality for mitral valve repair was 4·8% (2·1-9·0) and 6·8% (2·9-10·1) for mitral valve replacement. 22 (96%) of 23 patients were New York Heart Association (NYHA) class III or IV at baseline. The implantation of at least one device was successful in all patients, resulting in procedural residual mitral regurgitation of grade 2+ or less in 22 (96%) patients. Six (26%) of 23 patients had two implants. Periprocedural complications occurred in two (9%) of 23 patients (one minor bleeding event and one transient ischaemic attack). Despite the anatomical complexity of mitral regurgitation in the patients in this compassionate use cohort, technical success was achieved in 22 (96%) of 23 patients, and device success at 30 days was achieved in 18 (78%) patients. Three patients (13%) died during the 30 day follow-up. 19 (95%) of 20 patients alive 30 days after implantation were NYHA class I or II.nnnINTERPRETATIONnThis study establishes feasibility of the Edwards PASCAL TMVr system with a high rate of technical success and reduction of mitral regurgitation severity. Further research is needed on procedural and long-term clinical outcomes.nnnFUNDINGnNone.

Impact of baseline tricuspid regurgitation on long-term clinical outcomes and survival after interventional edge-to-edge repair for mitral regurgitation.

AimsTricuspid regurgitation (TR) in patients with mitral valve disease is associated with poor outcome and mortality. Only limited data on the impact of TR on functional outcome and survival in patients undergoing MitraClip procedures are available.Methods and results261 patients (mean age 76.6xa0±xa010, EuroScore 15.9xa0±xa015.1%) with symptomatic mitral regurgitation (MR) (75.2% functional MR) undergoing MitraClip procedure were included and followed for 721xa0±xa019.4xa0days. At baseline 54.7% presented with TR grade 0/I, 29.5% with grade II, 13.4% with grade III and 2.3% with grade IV. When dividing groups according to baseline TR grades, follow-up (FU)-NYHA class was significantly improved only in patients with TRxa0≤xa0II (pxa0=xa00.05). FU-6-min walking distance increased significantly in the overall cohort (pxa0=xa00.05), in patients with TRxa0≤xa0II (pxa0=xa00.007), but not in patients with TRxa0>xa0II (pxa0=xa00.4). Moreover, FU-NT-pro-BNP levels were higher in patients with TRxa0>xa0II (pxa0=xa00.05), compared to patients with TRxa0≤xa0II. There was a higher mortality according to baseline TRxa0>xa0II and multivariate Cox regression revealed TRxa0>xa0II as the strongest independent predictor for mortality (hazard ratio 2.04).ConclusionsConcomitant TR at baseline negatively influences functional outcome and mortality in patients undergoing MitraClip procedures. Our results underline the need for dedicated interventional strategies for the treatment of TR in patients with symptomatic MR.

Impact of interventional edge-to-edge repair on mitral valve geometry

BACKGROUND/OBJECTIVESnThe acute and long-term effects of interventional edge-to-edge repair on the mitral valve (MV) geometry are unclear. We sought to assess MV-annular geometry and the association of changes in MV-diameters with functional response one year after MitraClip implantation.nnnMETHODSnConsecutive patients (n=84; age 81.2±8.3years, logistic EuroSCORE 21.7±17.9%) with symptomatic moderate-to-severe mitral regurgitation (MR) underwent MitraClip-procedure. MV-annular geometry was assessed with 3D TOE before, immediately and one year after clip implantation.nnnRESULTSn96.7% of secondary mitral regurgitation (SMR) patients presented with moderate-to-severe MR, 3.3% with severe SMR, respectively. 66.7% of primary MR (PMR) patients had moderate-to-severe MR, and 33.3% severe PMR respectively. When analyzing immediate effects of MitraClipC on mitral geometry, only patients with SMR (n=60, 71.4%) experienced significant reductions of the diastolic MV anterior-posterior diameters (AP: 3.9±0.5cm, 3.5±0.7cm; p<0.001), and annulus-areas (2D: 12.9±3.8cm2, 12.6±3.7cm2; p<0.001; 3D: 13.4±3.8, 13.1±3.2cm2; p<0.001). All measures on MV annular geometry were not significantly altered in patients with PMR (p>0.05). After one year of follow-up, MV annular parameters remained significantly reduced in SMR patients (p<0.05) and remained unchanged in subjects with PMR (p>0.05). Only SMR patients experienced significant increase in 6min walking distances (p=0.004), decrease in pulmonary pressures (p=0.007) and functional NYHA-class (p<0.001); in patients with PMR only NYHA class improved after one year (p<0.001).nnnCONCLUSIONnEdge-to-edge repair with the MitraClip-system impacts on MV-geometry in patients with SMR with stable results after 12months. Reduction of MV-annular dimensions was associated with higher rates of persisting MR reduction and better functional status in patients with SMR.

Impact of endoscopic lung volume reduction on right ventricular myocardial function.

Introduction Endoscopic lung volume reduction (ELVR) provides a minimally invasive therapy for patients with severe lung emphysema. As its impact on right ventricular (RtV) function is undefined, we examined the extent of RtV functional changes following ELVR, as assessed by use of speckle tracking-based RtV deformation analysis. Methods We enrolled 32 patients with severe emphysematous COPD scheduled for bronchoscopic LVR using endobronchial valves (Zephyr, PulmonX, Inc.), comprising 16 matched clinical responders and 16 non-responders. Echocardiography was conducted one day prior to ELVR and at an eight-week postprocedural interval. Results Patients were predominantly of late middle-age (65.8±8.7yrs), male (62.5%) and presented advanced COPD emphysema (means FEV1 and RV: 32.6% and 239.1% of predicted, respectively). After ELVR, RtV apical longitudinal strain improved significantly in the total study cohort (-7.96±7.02% vs. -13.35±11.48%, p=0.04), whereas there were no significant changes in other parameters of RtV function such as RtV global longitudinal strain, TAPSE or pulmonary arterial systolic pressure. In responding patients, 6MWT-improvement correlated with a decrease in NT-proBNP (Pearson´s r: -0.53, p=0.03). However, clinical non-responders did not exhibit any RtV functional improvement. Discussion ELVR beneficially impacts RtV functional parameters. Speckle tracking-based RtV apical longitudinal strain analysis allows early determination of RtV contractile gain and identification of clinical responsiveness.