German Transcatheter Mitral Valve Interventions Research Articles

Impact of left atrial diameter on outcome in patients undergoing edge-to-edge mitral valve repair: results from the German TRAnscatheter Mitral valve Interventions registry (TRAMI)

Abstract Background Left atrium (LA) dimension is a marker of disease severity and outcome in primary and secondary mitral regurgitation. In transcatheter mitral valve repair LA enlargement might additionally impact on device handling and technical success through an altered anatomy and atrial annular dilatation. Methods Data from the multicenter German transcatheter mitral valve intervention registry “TRAMI” were used to analyse the association of baseline LA diameter by tertiles and efficacy, safety and long-term clinical outcome in patients undergoing edge-to-edge repair with the MitraClip. Results In 520 of 843 patients prospectively enrolled in TRAMI baseline LA diameter were reported (median [interquartile range] LA diameter in tertiles: 44 [40–46] mm, 51 [48–53] mm and 60 [55–66] mm). Larger LA diameters were significantly associated with secondary etiology of mitral regurgitation, lower ejection fraction, larger left ventricle, male sex and atrial fibrillation (all p<0.05). Technical success was not different across tertiles (96%, 95.4%, 98.4% respectively, p=0.43) as were major in-hospital cardiovascular and cerebral adverse events (mortality, myocardial infarction or stroke) (1.8%, 1.2% and 4.4%, p=0.11 across tertiles). However, 4-year mortality significantly increased with larger LA diameter (32.9%, 46.4% and 51.7% respectively, p<0.01), as did hospitalization in survivors (60%, 67.6% and 78.9% respectively, p<0.05). The association between LA diameter and all-cause mortality remained significant after multivariable adjustment including baseline left ventricular end-diastolic diameter. Conclusion LA enlargement is a strong and independent predictor of adverse long-term outcome in mitral regurgitation suggesting that timely transcatheter mitral valve repair may have the potential to modify outcome. Funding Acknowledgement Type of funding source: Private grant(s) and/or Sponsorship. Main funding source(s): The TRAMI registry has been supported by proprietary means of IHF. Additional funding is provided by “Deutsche Herzstiftung” and a grant from Abbott Vascular.

Impact of left atrial diameter on outcome in patients undergoing edge-to-edge mitral valve repair: results from the German TRAnscatheter Mitral valve Interventions (TRAMI) registry.

Left atrial (LA) dimension is a marker of disease severity and outcome in primary and secondary mitral regurgitation. In transcatheter mitral valve repair, LA enlargement might additionally impact on device handling and technical success through an altered anatomy and atrial annular dilatation. Data from the multicentre German TRAnscatheter Mitral valve Interventions registry (TRAMI) were used to analyse the association of baseline LA diameter by tertiles with efficacy, safety and long-term clinical outcome in patients undergoing edge-to-edge repair with MitraClip. In 520 of 843 patients prospectively enrolled in TRAMI, baseline LA diameter were reported [median (interquartile range) LA diameter in tertiles: 44 (40-46)mm, 51 (48-53)mm and 60 (55-66)mm]. Larger LA diameters were significantly associated with secondary aetiology of mitral regurgitation, lower ejection fraction, larger left ventricle, male sex and atrial fibrillation (all P < 0.05). Technical success was not different across tertiles (96%, 95.4% and 98.4%, respectively; P=0.43) as were major in-hospital cardiovascular and cerebral adverse events (mortality, myocardial infarction or stroke: 1.8%, 1.2% and 4.4%, respectively; P=0.11 across tertiles). However, 4-year mortality significantly increased with larger LA diameter (32.9%, 46.4% and 51.7%, respectively; P < 0.01), as did hospitalization in survivors (60%, 67.6% and 78.9%, respectively; P < 0.05). The association between LA diameter and outcome remained significant after multivariable adjustment including baseline left ventricular end-diastolic diameter. Left atrial enlargement is a strong and independent predictor of adverse long-term outcome after transcatheter mitral valve repair. Further study is warranted to examine whether timely intervention may have the potential to modify outcome.

Underweight is associated with inferior short and long-term outcomes after MitraClip implantation: Results from the German TRAnscatheter mitral valve interventions (TRAMI) registry

Underweight and obesity represent classical risk factors for adverse outcome in patients treated for cardiovascular disease. The current analysis examines the impact of underweight, overweight and obesity on intra-hospital, short and long-term outcomes in patients treated by MitraClip therapy. From August 2010 until July 2013, 799 patients (age 75.3 ± 8.6 years, male gender 60.7%, median logistic EuroSCORE 20% [12; 31], functional mitral regurgitation (MR): 69.3%) were prospectively enrolled into the multicenter German Transcatheter Mitral Valve Interventions registry. Patients were stratified according to body mass index (BMI) into 4 groups: BMI <20 kg/m2 (underweight), BMI 20.0 to <25.0 kg/m2 (normal weight, reference group), BMI 25.0 to <30.0 kg/m2 (overweight) and BMI ≥30 kg/m2 (obese). Significant increased rates of procedural failure, transfusion/bleeding, sepsis or multiorgan failure and low cardiac output failure were found for underweight patients only. Kaplan-Meier survival curves demonstrated inferior survival for underweight patients, but comparable outcomes for all other patients (global log rank test, P < .01). Multivariable Cox-regression analysis (adjusted for age, gender, creatinine ≥1.5 mg/dL, diabetes, left ventricular ejection fraction <30% and chronic obstructive pulmonary disease) confirmed underweight (as compared to normal weight) as an independent risk factor of death (hazard ratio [HR]: 1.58, 95% confidence interval (CI): 1.01-2.46, P = .044) and overweight as protective against death (HR: 0.71; 95%-CI: 0.55-0.93; P = .011). Compared to other weight groups, underweight patients undergoing MitraClip implantation are exposed to increased rates of procedural failure, bleeding and low cardiac output as well as increased short- and long-term mortality rates and should therefore be carefully discussed in the heart-team.

1635 Catch me if you can: a rare case of two-staged MitraClip detachment

Abstract Case report A 74-year-old man presented with acute heart failure and chronic obstructive pulmonary disease exacerbation. His medical history revealed: anterior myocardial infarction in 2005, treated with primary PCI of left anterior descending coronary artery followed by triple coronary artery bypass, atrial fibrillation, hypertension, diabetes mellitus and obesity. Transthoracic and transesophageal echocardiography (TEE) showed severe functional ischemic mitral regurgitation (MR) with multiple jets, the main one involving the A2-P2 scallops due to asymmetric tethering of the posterior leaflet. The vena contracta diameter (VC) was 8 mm, the effective regurgitant orifice area (EROA) 0.53 cm². Global left ventricular (LV) function was preserved with inferior-posterior wall akinesis. After "Heart Team" discussion, due to high surgical risk, the patient was referred for percutaneous mitral valve repair (PMVR) using MitraClip (MC) system (Abbott Vascular, Illinois). One clip (MC-XTR) was placed at the A3-P3 segments; subsequently, prior to releasing a second clip (MC-XTR), the first one partially detached from the posterior leaflet (Fig A). A third clip (MC-NTR) was implanted medially. The grasp was challenging but at the end of the procedure, the first clip appeared stable and marked reduction of MR was achieved (Fig B). 7 days later, the patient became symptomatic for resting dyspnea and worsened his clinical status. A control 2D-3D TEE revealed a complete detachment of the first implanted clip, visible distally into the LV, trapped in the mitral valve subchordal apparatus (Fig C). This resulted in massive MR (VC: 12 mm, EROA: 0.91 cm²) with an eccentric posteriorly directed regurgitant jet (Fig D). The patient underwent emergency surgical retrieval of the migrated clip, and removal of the torn mitral valve anterior leaflet. The other two clips were also removed (Fig E), and a bioprosthetic mitral valve was implanted. The procedure was completed uneventfully and the patient is in stable conditions at 2-months follow-up. Discussion The constant stretching and whip effect of the mitral leaflets captured between the clips arms, used in PMVR, can lead to complications. Partial clip detachment is a rare adverse event described in ∼0.7-4.9% of patients within 30 days after MC intervention*. We experienced a two-staged MC detachment that is an even rarer complication and requires emergency surgery. In addition, we highlights the usefulness of 3D TEE for early diagnosis and better imaging characterization in patients who develop complications after MC procedure. No conflict of interest. *Puls M, Lubos E, Boekstegers P, von Bardeleben RS, Ouarrak T, Butter C, Zuern CS, Bekeredjian R, Sievert H, Nickenig G, Eggebrecht H, Senges J, Schillinger W. One-year outcomes and predictors of mortality after MitraClip therapy in contemporary clinical practice: results from German transcatheter mitral valve interventions registry. Eur Heart J 2016;37:703-12. Abstract 1635 Figure.

P4730Underweight is associated with unfavourable short- and long-term outcomes after MitraClip therapy: a body mass index derived subgroup analysis of the German Transcatheter Mitral Valve Interventions (

Abstract Background Underweight and obesity represent classical risk factors for patients undergoing cardiac surgery or interventional treatment. The multicentre German Transcatheter Mitral Valve Interventions (TRAMI) registry comprises a large and prospectively enrolled real-world cohort of patients treated by MitraClip implantation. Aims The current analysis examines the impact of underweight, overweight and obesity on intra-hospital, short and long-term outcomes in patients treated by MitraClip therapy. Methods and results From 08/2010 until 07/2013, 799 patients (age 75.3±8.6 years, male gender 60.7%, median logistic EuroSCORE 20% [12; 31], functional mitral regurgitation (MR): 69.3%) were prospectively enrolled into the multicentre, industry-independent German Transcatheter Mitral Valve Interventions registry. Patients were stratified according to body mass index (BMI) into four groups: BMI&lt;20 kg/m2 (underweight, n=49), BMI 20.0 to &lt;25.0 kg/m2 (normal weight, n=293), BMI 25.0 to &lt;30.0 kg/m2 (overweight, n=296) and BMI≥30 kg/m2 (obese, n=132). Procedure and radiation time were comparable among all groups. Significant increased rates of procedural failure (12.2% vs. 2.1 [normal weight], p&lt;0.001), transfusion/bleeding (20.8% vs. normal weight: 5.6%, obesity: 7.0%, p&lt;0.01), sepsis or multiorgan failure and low cardiac output failure were found for underweight patients only. Kaplan-Meier survival curves demonstrated inferior survival for underweight patients, but comparable outcomes for all other patients (global log rank test, p&lt;0.01). Multivariable Cox-regression analysis (adjusted for age, gender, creatinine≥1.5mg/dl, diabetes, left ventricular ejection fraction&lt;30% and chronic obstructive pulmonary disease) confirmed underweight (as compared to normal weight) as an independent risk factor of death (hazard ratio [HR]: 1.58, 95%-confidence interval (CI): 1.01–2.46, p=0.044) and overweight as protective against death (HR: 0.71; 95%-CI: 0.55–0.93; p=0.011). Conclusion Underweight patients are exposed to increased rates of procedural failure, bleeding and low cardiac output as well as increased short- and long-term mortality rates when undergoing MitraClip implantation and should therefore be carefully discussed within the heart team. Acknowledgement/Funding The TRAMI registry has been supported by proprietary means of IHF. Additional funding is provided by “Deutsche Herzstiftung” and a grant from Abbott.

Percutaneous treatment of mitral regurgitation in patients with impaired ventricular function: Impact of intracardiac electronic devices (from the German Transcatheter Mitral Valve Interventions Registry).

To identify prevalence/impact of previous implantation of cardiac electronic devices (CEDs), such as cardioverter defibrillator (ICD) and cardiac resynchronization (CRT), in a group of MitraClip (MC) candidates with LVEF < 30%. MC therapy is nowadays often considered in patients with depressed left ventricular ejection fraction (LVEF%) and symptomatic severe secondary MR. Data from the German Transcatheter Mitral Valve Interventions (TRAMIs) registry were analyzed. Patients with pre-procedural LVEF <30% were selected and divided according to the presence of CEDs. Pre-procedural, peri-procedural, and 1-year follow-up data were analyzed. Out of 689 MC patients, 235 had LVEF<30%. Of these, 23% (54/235) had CRT, 36.6% (86/235) ICD, and 40.4% (95/235) had no CEDs. Risk profile was similar (median STS score CRT 6.0 (IQR: 3.0-12.0); ICD 7.0 (IQR: 4.0-12.0); No-CED 6.5 (IQR: 2.0-10.0); p = 0.8). No procedural mortality was observed and hospital mortality was 5.6% in CRT, 2.3% in ICD, and 3.2% in No-CED (p = 0.5). At discharge, severe MV regurgitation was reported in 3.8% of CRT, 3.7% of ICD, and 1.1% of No-CED (p = 0.9). One year estimated survival (CRT 75.7%; ICD 75.8%; No-CED 78%; p = 0.94) and freedom from MACCE (CRT 73.6%; ICD 75.8%; No-CED 74.5%; p = 0.88) were similar. A third of patients have been already submitted to CEDs implantation at time of referral for MC therapy and 40% of those with severely depressed LVEF% arrive to MC therapy before ICD/CRT implantation. The presence of CED does not impair acute MC therapy success. Mid-term follow-up outcomes are similar in patients with and without CEDs.

Long-term outcome, survival and predictors of mortality after MitraClip therapy: Results from the German Transcatheter Mitral Valve Interventions (TRAMI) registry

BackgroundMitraClip therapy is increasingly used in patients deemed inoperable to treat severe mitral regurgitation (MR), but long-tern data is scarce. AimsThe multicentre, industry-independent German Transcatheter Mitral Valve Interventions (TRAMI) registry comprises the largest prospectively enrolled cohort of patients treated by MitraClip therapy. The current analysis is focusing on long-term mortality rates, cardiac rehospitalization and reintervention. Methods and resultsLong-term follow-up (median time 1037 days) in the TRAMI registry was available for 722 patients treated at 20 German centres. Improvements in New York Heart Association (NYHA) functional class (I/II long-term: 65% vs. 1-year follow-up: 63.3%) and self-rated health-status (EuroQuol visual analogue scale [EQ VAS] long-term: 60 [50–70] vs. 1-year follow-up: 60 [50; 70]) were pertained over time.Estimated mortality rates by Kaplan-Meier method were 19.7% for 1-year, 31.9% for 2-year and 53.1% for 4-year follow-up without differences found for MR aetiology. Multivariable Cox-regression analysis identified previous aortic valve implantation (hazard ratio [HR] = 2.21; p < 0.0001), NYHA class IV (HR = 1.78; p < 0.001), prior cardiac decompensation (HR = 1.63; p < 0.001), creatinine > 1.5 mg/dl (HR = 1.63; p < 0.0001) and left ventricular ejection fraction < 30% (HR = 1.60; p < 0.001) as most predictive for long-term mortality. ConclusionsLong-term outcome in the TRAMI registry confirmed lasting clinical improvements and low intervention rates. Long-term mortality was strongly influenced by cardiac and non-cardiac co-morbidities and was found comparable for both MR aetiologies.

1210Long-term follow-up in the German TRAnscatheter mitral valve Interventions (TRAMI) registry: survival and predictors of mortality

1210Long-term follow-up in the German TRAnscatheter mitral valve Interventions (TRAMI) registry: survival and predictors of mortality

Prognostic value of preprocedural 6-min walk test in patients undergoing transcatheter mitral valve repair-insights from the German transcatheter mitral valve interventions registry.

The 6-min walk test (6 MWT) has been established as an important tool for functional assessment in heart failure patients. However, its prognostic impact on the outcome in subjects with mitral regurgitation undergoing transcatheter mitral valve repair is unknown. This present work represents a sub-analysis of the German, prospective, multicenter, Transcatheter Mitral Valve Interventions (TRAMI) registry. Of the main study cohort (n = 828) 326 patients underwent 6 MWT prior to the procedure. Patients were assigned to two groups depending on the preprocedural 6 MWT distance using the median (< 200m [group 1] vs. ≥ 200m [group 2]). No differences regarding procedural success (97 vs. 96%; p = 0.71) and 30-day mortality (3 vs. 4%; p = 0.96) were observed between the groups. With regards to 1-year outcome, patients with a walking distance < 200m had higher all-cause mortality (26 vs. 14%; p = 0.013) as compared to those with a 6 MWT distance 200m. After adjustment of baseline risk factors, 6 MWT distance < 200m still showed a strong trend towards increased 1-year all-cause mortality (HR 1.63, 95% confidence interval 0.96-2.76; p = 0.071). In the present study preprocedural 6 MWT distance < 200m showed a strong trend towards increased 1-year mortality in patients undergoing MitraClip implantation.

Safety and efficacy of MitraClip™ therapy in patients with severely impaired left ventricular ejection fraction: results from the German transcatheter mitral valve interventions (TRAMI) registry.

The aim of the present study was to assess the safety and efficacy of percutaneous mitral valve repair using the MitraClip™ device in patients with severely reduced systolic left ventricular (LV) function. Among 777 MitraClip™ implantations included in the German mitral valve registry, we identified 256 patients suffering from severely reduced LV function [ejection fraction (EF) <30%] in whom successful percutaneous mitral valve repair was performed. Procedural safety, efficacy, and 1-year outcome was compared with 241 patients with preserved LV function (EF >50%) and 280 patients presenting with an EF 30-50% prior to MitraClip™ therapy. High procedural success rates, low periprocedural complication rates, and low residual mitral regurgitation grades at discharge were achieved throughout all groups. In-hospital mortality was low and comparable in all groups. After 1 year, mortality rates were 24.2% (EF <30%), 17.3% (EF 30-50%), and 18.9% (EF >50%). Major adverse cardiac or cardiovascular event rates were 29.7% (EF <30%), 24.4% (EF 30-50%), and 23.5% (EF >50%). Procedural failure was the main predictor for mortality in EF <30% patients (hazard ratio 10.38; 95% CI 3.71-29.02). Improved clinical symptoms were observed in the majority of patients in all groups. Thus, 69.5% of EF <30% patients improved by one or more New York Heart Association functional class. Compared with patients with preserved LV function, this is a significantly larger proportion (EF >50%: 56.8%; P < 0.05). Moreover, quality of life, being very poor at baseline, improved distinctively in severe heart failure patients. In patients with severely reduced systolic LV function undergoing MitraClip™ therapy, procedural safety, efficacy, and clinical improvement after 1 year are comparable to patients with preserved LV function.

Implication of pulmonary hypertension in patients undergoing MitraClip therapy: results from the German transcatheter mitral valve interventions (TRAMI) registry.

We sought to evaluate the impact of pulmonary hypertension on outcomes following MitraClip therapy. The 643 patients in the TRAnscatheter Mitral valve Interventions (TRAMI) registry were divided into three groups according to echocardiographically graded systolic pulmonary artery pressure (sPAP) (Group 1: patients with sPAP of ≤36 mmHg; Group 2: patients with sPAP of 37-50 mmHg; Group 3: patients with sPAP of >50 mmHg) and followed for 1 year. Recent cardiac decompensation, aortic valve disease and tricuspid valve insufficiency were observed more frequently in patients with higher sPAP. Furthermore, logEuroSCORE, Society of Thoracic Surgeons score and age were higher with rising sPAP values. No differences were observed in mitral regurgitation (MR) severity, co-morbidities or clinical findings (New York Heart Association class, 6-min walking distance). Reduction to MR of grade 1 or lower was achieved more often in patients with lower sPAP levels (P = 0.01). In Groups 2 and 3, sPAP was reduced significantly. Major adverse cardiac or cardiovascular events (MACCEs) occurring in hospital (death, myocardial infarction, stroke; <4% in each group), as well as 30-day rates of MACCEs (6.1% in Group 1, 11.9% in Group 2, 12.4% in Group 3) and rehospitalization (18.9% in Group 1, 24.8% in Group 2, 24.8% in Group 3) did not differ significantly. At 1 year, differences in rates of mortality and MACCEs (20.3% in Group 1, 33.1% in Group 2, 34.7% in Group 3; P < 0.01) were significant. Both Groups 2 [hazard ratio (HR) 1.81, P = 0.0122] and 3 (HR 1.85, P = 0.0092) were independently predictive of death. Rehospitalization rates did not differ during follow-up. Despite higher mortality in patients with elevated sPAP, these data suggest the safety, feasibility and benefit of MitraClip therapy even in advanced stages of disease. An early approach might prevent the progress of pulmonary hypertension and improve outcomes.

Combined mitro-aortic pathology: impact of previous aortic valve replacement upon outcomes of MitraClip therapy (from the German transcatheter mitral valve interventions registry).

The aim of this study was to identify the impact of previous aortic valve replacement (AVR) in MitraClip (MC) patients. Data from the German transcatheter mitral valve interventions (TRAMI) registry were analysed in the light of previous AVR by means of either standard AVR (SAVR) or transcatheter AVR (TAVR). Out of 791 MC patients, 68 (8.6%) had been submitted to AVR (68.4% SAVR and 31.6% TAVR). The AVR group was significantly older (77.2±8.0 years vs. 75.1±8.6 years; p<0.05) and had a trend towards a higher risk profile (median STS score 10 [8.0-12.0] vs. 6.0 [3.0-11.0]; p=0.1). No procedural mortality was observed. Severe residual MV regurgitation was reported in 6.2% of AVR vs. 3.7% of the no-AVR patients (p=0.1). Thirty-day mortality was 10.6% in the previous AVR group vs. 3.9% in the no-AVR group (p<0.05). One-year estimated survival was lower in the AVR group (AVR 63% vs. no-AVR 81%; p<0.0001; HR 2.25, 95% CI: 1.42-3.55). Estimated survival in TAVR compared to SAVR was lower (TAVR 44.4% vs. SAVR 70%; p=0.039; HR 2.32, 95% CI: 0.99-5.37). AVR was a determinant of follow-up mortality (HR 2.18, 95% CI: 1.4-3.4; p<0.001). Previous AVR in patients undergoing MC therapy carries a heavy and independent burden of mortality/morbidity.

Impact of cardiac comorbidities on early and 1-year outcome after percutaneous mitral valve interventions: data from the German transcatheter mitral valve interventions (TRAMI) registry.

The use of the MitraClip system has gained widespread acceptance for the treatment of patients with mitral regurgitation (MR) who are not suitable for the conventional surgery. This study sought to investigate the early and 1-year outcome after MitraClip therapy of patients with MR and cardiac comorbidities. Outcomes through 12-month follow-up of patients (n=528) who underwent MitraClip implantation were obtained from the German transcatheter mitral valve interventions (TRAMI) registry. The majority of these patients (n=409, 77.5%) also suffered from coronary artery disease (CAD). Patients with a dilated cardiomyopathy (DCM, n=65, 12.3%) or concomitant valvular aortic disease (AV, n=54, 10.2%) were less frequent. Although the prevalent pathogenesis was functional MR, patients with DCM had significantly more frequent a functional MR (96.9%) compared to patients with CAD (74.9%) or AV (62.5%, p<0.001). Technical success was achieved in 97.5% of patients. Procedural echocardiograms demonstrated in the vast majority of patients a reduction from severe MR III to mild MR I with no difference between the groups (p=0.83). The peri-procedural complication rate was very low. At 30-day and 12-month follow-up, the majority of patients were in NYHA functional class II or lower. The rate of death, stroke, and myocardial infarction (MACCE) was comparable in the three patient groups during 12-month follow-up (DCM 26.9%, CAD 30.3% and AV 27.5%, p=0.85). The MitraClip implantation is feasible and safe even in high-risk patients with MR and cardiac comorbidities.

Predictors for short-term outcomes of patients undergoing transcatheter mitral valve interventions: analysis of 778 prospective patients from the German TRAMI registry focusing on baseline renal function.

Factors predicting outcomes after MitraClip implantation are not well defined. We aimed to report the influence of baseline renal function on short-term outcomes of patients enrolled in the investigator-initiated German transcatheter mitral valve interventions (TRAMI) registry. Twenty participating German centres prospectively included 778 patients (mean age 76.0 years [71-81], 38.8% female gender) at high surgical risk (mean logistic EuroSCORE 20% [12-32%]) undergoing TMVR with the MitraClip for the treatment of symptomatic functional (70%) or degenerative (30%) mitral valve regurgitation (FMR, DMR). The patients were stratified according to renal function before clip implantation. The prevalence of moderate to severe renal impairment (glomerular filtration rate [GFR] <60 ml/min) was 62.7% (37.3%, normal renal function [GFR >60 ml/min]; 49.6%, moderate renal impairment [GFR 30-60 ml/min]; 13.1%, severe renal impairment [GFR <30 ml/min]). TMVR was successfully completed in 98.2% of cases; acute procedural failure, in-hospital and 30-day mortality rates were 1.8%, 2.3% and 4.4%, respectively. Acute procedural failure and mortality rates (in-hospital, 30-day) were significantly higher in patients with severe renal impairment (5.9%, 7.8%, 14.1%), as compared to patients with moderately (1%, 1.3%, 3.0%) or mildly impaired to normal (1.4%, 1.7%, 2.9%) renal function (p<0.0001). Following Cox regression analysis, the prevalence of severe renal impairment at the time of TMVR was the only predictor for increased 30-day mortality rates (hazard ratio 3.42, 95% confidence interval 1.88-6.2; p<0.0001). Renal function at the time of interventional mitral valve repair with the MitraClip system is a strong predictor for procedural outcomes. Patients with severe renal impairment have a more than threefold increased risk for acute procedural failure, in-hospital death and 30-day mortality.

Influence of non-cardiac comorbidities on outcome after percutaneous mitral valve repair: results from the German transcatheter mitral valve interventions (TRAMI) registry.

To investigate the influence of non-cardiac comorbidities on outcomes of patients enrolled in the German transcatheter mitral valve interventions (TRAMI) registry. Intrahospital and 30-day MACCE rates (death of all causes, stroke and myocardial infarction) of 828 patients from the TRAMI registry were stratified by the number of non-cardiac comorbidities. The following non-cardiac comorbidities were prospectively recorded in the registry: diabetes, renal insufficiency, extracardiac arteriopathy, chronic lung disease, neurological disease or malignancy on palliative care. The 375 (45.3%) patients with multiple (≥2) non-cardiac comorbidities presented with higher NYHA classes, higher logistic Euroscores, higher levels of NT-proBNP and a shorter 6-min walk distance. Rates of intraprocedural death (0.3 vs. 0.0%, p=0.41) and intrahospital MACCE (3.6 vs. 1.9%, p=0.16) were not significantly higher in patients with multiple non-cardiac comorbidities, but 30-day MACCE rate was significantly enhanced (6.4 vs. 3.6%, p=0.049). However, both patient groups showed a similar clinical improvement after 30days. Renal insufficiency was the only non-cardiac comorbidity which was independently associated with the 30-day MACCE rate. MitraClip device placement is feasible and safe in patients with multiple non-cardiac comorbidities resulting in a significant clinical improvement and acceptable intrahospital and 30-day event rates. Renal failure is an independent predictor of outcome.

Risk and outcomes of complications during and after MitraClip implantation: Experience in 828 patients from the German TRAnscatheter mitral valve interventions (TRAMI) registry.

To analyze risk and outcomes of complications during and after MitraClip implantation using multicenter data from the prospective German Transcatheter Mitral Valve Interventions (TRAMI) registry. Data of 828 patients (mean age: 76.0 [71-81] years, 327 (40%) females) undergoing MitraClip implantation in Germany between 2010 and 2013 were analyzed. Most patients (85%) underwent elective procedures with on average implantation of 1.4 ± 0.6 clips. Emergent cardiac surgery was not required; a single patient died intraoperatively. During the in-hospital period, complications occurred in 215 (25.9%) patients, of which 106 (12.8%) were considered major. Major bleeding complications were among the most frequent major complications (7.4%), while rates of pericardial tamponade (1.9%) and clip-specific complications (embolization: 0%, partial clip detachment: 1.9%) were low. In-hospital death, stroke or myocardial infarction (MACCE) occurred in 2.2, 0.9, and 0% patients, respectively. Patients with complications appeared to be older and more critically ill pre-interventionally; in-hospital mortality was significantly higher as compared to those without procedural complications. MitraClip implantation appears to be a safe treatment option with low rates of MACCE and clip-specific complications. Nevertheless, MitraClip therapy is not without complications. Careful patient selection and improvements in preventing peri-procedural bleeding have the potential of reducing post-procedural complications and improving outcomes.

Percutaneous mitral valve repair with the mitraclip system according to the predicted risk by the logistic EuroSCORE: Preliminary results from the German Transcatheter Mitral Valve Interventions (TRAMI) registry

To evaluate in-hospital and short-term outcomes of percutaneous mitral valve repair according to patients' logistic EuroSCORE (logEuroSCORE) in a multicenter registry The logEuroSCORE is an established tool to predict the risk of mortality during cardiac surgery. In high-risk patients percutaneous mitral valve repair with the MitraClip system represents a less-invasive alternative Data from 1002 patients, who underwent percutaneous mitral valve repair with the MitraClip system, were analyzed in the German Transcatheter Mitral Valve Interventions (TRAMI) Registry. A logEuroSCORE (mortality risk in %) ≥ 20 was considered high risk Of all patients, 557 (55.6%) had a logEuroSCORE ≥ 20. Implantation of the MitraClip was successful in 95.5 % (942/986) patients. Moderate residual mitral valve regurgitation was more often detected in patients with a logEuroSCORE ≥ 20 (23.8% vs. 17.1%, respectively, P < 0.05). In patients with a logEuroSCORE ≥ 20 the procedural complication rate was 8.9% (vs. 6.4, n.s.) and the in-hospital MACCE rate 4.9% (vs. 1.4% P < 0.01). The in-hospital mortality rate in patients with a logEuroSCORE ≥ 20 and logEuroSCORE < 20 was 4.3 and 1.1%, respectively (P ≤ 0.01) CONCLUSION: Percutaneous mitral valve repair with the MitraClip system is feasible in patients with a logEuroSCORE ≥ 20 with similar procedural results compared to patients with lower predicted risk. Although mortality was four times higher than in patients with logEuroSCORE < 20, mortality in high risk patients was lower than predicted. In those with a logEuroSCORE ≥ 20, moderate residual mitral valve regurgitation was more frequent.

Acute outcomes after MitraClip® therapy in highly aged patients: results from the German TRAnscatheter Mitral valve Interventions (TRAMI) Registry

The influence of age on baseline demographics and outcomes of patients selected for MitraClip has not been previously investigated. Baseline demographics and acute outcomes in 1,064 patients from the German TRAMI registry were stratified by age (525 patients ≥76 years and 539 patients <76 years). In elderly patients, logistic EuroSCORE was higher (25[15-40]% vs. 18[10-31]%, p<0.0001) and the proportion of women was greater (47.2% vs. 29.3%, p<0.0001). Elderly patients were more likely to have preserved left ventricular ejection fraction >50% (40.1% vs. 21.8%, p<0.0001) and degenerative mitral regurgitation (DMR, 35.3% vs. 25.6%, p<0.01). Age was the most frequent reason for non-surgical treatment in the elderly (69.4% vs. 36.1%, p<0.0001). The intrahospital MACCE (death, myocardial infarction, stroke) was low in both groups (3.5% vs. 3.4%, p=0.93) and the proportion of non-severe mitral regurgitation at discharge was similar (95.8% vs. 96.4%, p=0.73). A logistic regression model did not reveal any significant impact of age on acute efficacy and safety of MitraClip therapy. In both groups, the majority of patients were discharged home (81.8% vs. 86.2%, p=0.06). Elderly and younger patients have similar benefits from MitraClip therapy. Age was the most frequent cause for denying surgery in elderly patients.

MitraClip therapy in daily clinical practice: initial results from the German transcatheter mitral valve interventions (TRAMI) registry

A substantial percentage of patients with mitral regurgitation (MR) in need of mitral valve repair are currently considered not suitable for conventional surgery. In Germany, the largest cohort of patients studied to date has been treated using a percutaneous, catheter-based approach. We report the acute outcomes of patients enrolled in the investigator-initiated German transcatheter mitral valve interventions (TRAMI) registry. Between January 2009 and August 2011, 486 patients [median age 75 (interquartile range 70-80) years; 200 women (41%)] were enrolled in the registry (309 retrospectively and 177 prospectively), with 481 patients (99%) having undergone percutaneous edge-to-edge therapy for MR using the MitraClip. At baseline, 93% of patients were in New York Heart Association (NYHA) functional class III or IV and 71% of patients had a left ventricular ejection fraction (LVEF) ≤50%. Two-thirds of patients presented with functional MR. Procedural success was achieved in 94% of patients, with grade III present in 93% of patients at baseline yet only 6% post-intervention. Retrospective patients were followed for a median of 183 days, prospective patients for a median of 44 days. The periprocedural complication rate was low, with only minor bleedings as the most significant event. In-hospital and post-discharge mortality was 2.5% and 12.5%, respectively. Data from the German TRAMI registry suggest that MitraClip therapy is a viable treatment option in daily clinical routine for high surgical risk patients with significant MR.