Transcatheter Mitral Valve Interventions Registry 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.

Combined Tricuspid and Mitral Versus Isolated Mitral Valve Repair for Severe MR and TR: An Analysis From the TriValve and TRAMI Registries

ObjectivesThe aim of this study was to retrospectively compare the characteristics, procedural courses, and outcomes of patients presenting with concomitant mitral regurgitation (MR) and tricuspid regurgitation (TR) in the TriValve (Transcatheter Tricuspid Valve Therapies) and TRAMI (Transcatheter Mitral Valve Interventions) registries. BackgroundTranscatheter mitral edge-to-edge valve repair (TMVR) has been shown to be successful in patients with severe MR. Lately, edge-to-edge repair has also emerged as a possible treatment for severe TR in patients at high risk for cardiac surgery. In patients with both severe MR and TR, the yield of concomitant transcatheter mitral and tricuspid valve repair (TMTVR) for patients at high surgical risk is unknown. MethodsThe characteristics, procedural data, and 1-year outcomes of all patients in the international multicenter TriValve registry and the German multicenter TRAMI registry, who presented with both severe MR and TR, were retrospectively compared. Patients in TRAMI (n = 106) underwent isolated TMVR, while those in TriValve (n = 122) additionally underwent concurrent TMTVR in compassionate and/or off-label use. ResultsAll 228 patients (mean age 77 ± 8 years, 44.3% women) presented with significant dyspnea at baseline (New York Heart Association functional class III or IV in 93.9%), without any differences in the rates of pulmonary hypertension and chronic pulmonary disease. The proportion of patients with left ventricular ejection fraction <30% was higher in the TMVR group (34.9% vs. 18.0%; p < 0.001), while patients in the TMTVR group had lower glomerular filtration rates. At discharge, MR was comparably reduced in both groups. At 1 year, overall all-cause mortality was 34.0% in the TMVR group and 16.4% in the TMTVR group (p = 0.035, Cox regression). On multivariate analysis, TMTVR was associated with a 2-fold lower mortality rate (hazard ratio: 0.52; p = 0.02). The rate of patients in New York Heart Association functional class ≤II at 1 year did not differ (69.4% vs. 67.0%; p = 0.54). ConclusionsConcurrent TMTVR was associated with a higher 1-year survival rate compared with isolated TMVR in patients with both MR and TR. Further randomized trials are needed to confirm these results.

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.

1385Combined tricuspid and mitral vs. isolated mitral valve repair for severe mitral and tricuspid regurgitation: An analysis from TriValve and TRAMI registries

Abstract Background Edge-to-edge repair has been shown to be a successful therapeutic option for patients with severe mitral regurgitation (MR). Lately, it has also been emerging as a treatment perspective for severe tricuspid regurgitation (TR) in patients at high-risk for cardiac surgery. In patients, with both severe MR and TR the best treatment strategy for patients at high risk for surgery is unknown. Purpose and methods We retrospectively analyzed data from the international multicentre TriValve (Transcatheter Tricuspid Valve Therapies) registry and from the German multicentre TRAMI (Transcatheter Mitral Valve Interventions) registry. All patients included into the analysis had both severe MR and TR. Patients from the TRAMI registry (n=106) were treated with edge-to-edge repair in mitral position only. In patients from the TriValve registry (n=122), both valves were treated concomitantly in compassionate and/or off-label use. We sought to compare baseline characteristics, procedural data and 1-year mortality in both treatment groups. Results 228 patients (77±8 years; 44.3% female) were included into the analysis. All patients showed significant dyspnea on exposure (NYHA III or IV 93.9%). Kidney function (eGFR 42 ml/min/1,72m2) and the proportion of patients with significant pulmonary hypertension (59.0%) and COPD (23.7%) did not differ between the groups, but the proportion of patients with LV-EF &lt;30% (34.9% vs. 18.0%, p&lt;0.001) were higher in the TRAMI cohort. At discharge, MR was comparably reduced in both groups (MR ≤ I° 75.9% vs. 77.3%, p=0.67). While all patients in both registries had significant TR at baseline, the percentage of patients with TR≥3+ at discharge was reduced to 18.6% in TriValve by the placement of 2±1 tricuspid clips/patient. The rate of in-hospital adverse events and the time of hospitalization did not differ in both cohorts. At 1-year, overall all-cause mortality was 34.0% in the TRAMI cohort and 16.4% in the TriValve cohort (p=0.0002, see figure; after adjustment for LVEF &lt;30%: p=0.049). The rate of patients with NYHA ≤ II at 1 year did not differ between both cohorts (69.4% vs. 67.0%, p=0.54). 1-year mortality TriValve vs. TRAMI Conclusion Transcatheter mitral and tricuspid valve repair can result in a significant clinical improvement at 1 year. The concomitant treatment of both valve regurgitations may result in an improved survival, which needs to be confirmed in dedicated prospective trials.

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.

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.

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.

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.

TRAMI (Transcatheter Mitral Valve Interventions)-Register

The transcatheter mitral valve interventions (TRAMI) registry was established in 2010 in order to assess the safety and efficacy of percutaneous mitral valve therapy in Germany and to document baseline characteristics and decision-making in different subgroups of patients. The TRAMI registry is available to all German sites performing percutaneous mitral valve therapy. Follow-up is scheduled at 30 days, 1, 3, and 5 years. In addition, patients can be enrolled retrospectively without predefined times of follow-up. The vast majority of patients enrolled in TRAMI underwent MitraClip® therapy. As of March 2013, a total of 1,064 patients treated with MitraClip® have been enrolled at 21 different German sites. Preliminary results show that patients treated with MitraClip® in Germany were mainly elderly patients with significant comorbidities and high or inacceptable risk of surgery. The majority of patients had secondary mitral regurgitation and a large proportion of patients had reduced left ventricular ejection fraction (LV-EF). Nevertheless, MitraClip® was found to be safe and established risk factors for conventional cardiac mitral valve surgery, such as advanced age (≥76 years), female gender, severely reduced LV-EF (<30%) and high logistic EuroScore (≥20%) were not predictive for mortality or major complication rates. In contrast, severely reduced renal function was predictive for adverse outcome. The TRAMI registry is the largest real world cohort of patients treated with MitraClip®. As long as randomized studies in this high-risk cohort of patients are lacking, TRAMI provides important information on outcomes after MitraClip® therapy. The data are important for hypothesis generation for randomized trials and TRAMI is an important tool for quality assurance after percutaneous mitral valve therapy in Germany.

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.