Prediction of Mortality and Heart Failure Hospitalization After Transcatheter Tricuspid Valve Interventions: Validation of TRISCORE.

BACKGROUND: Data on the prognostic role of the TRI-SCORE in patients undergoing transcatheter tricuspid valve intervention (TTVI) are limited. OBJECTIVES: The aim of this study was to evaluate the performance of the TRI-SCORE in predicting outcomes of patients undergoing TTVI. METHODS: TriValve (Transcatheter Tricuspid Valve Therapies) is a large multicenter multinational registry including patients undergoing TTVI. The TRI-SCORE is a risk model recently proposed to predict in-hospital mortality after tricuspid valve surgery. The TriValve population was stratified based on the TRI-SCORE tertiles. The outcomes of interest were all-cause death and all-cause death or heart failure hospitalization. Procedural complications and changes in NYHA functional class were also reported. RESULTS: Among the 634 patients included, 223 patients (35.2%) had a TRI-SCORE between 0 and 5, 221 (34.8%) had 6 or 7, and 190 (30%) had ≥8 points. Postprocedural blood transfusion, acute kidney injury, new atrial fibrillation, and in-hospital mortality were more frequent in the highest TRI-SCORE tertile. Postprocedure length of stay increased with a TRI-SCORE increase. A TRI-SCORE ≥8 was associated with an increased risk of 30-day all-cause mortality and all-cause mortality and the composite endpoint assessed at a median follow-up of 186 days (OR: 3.00; 95% CI: 1.38-6.55; HR: 2.17; 95% CI: 1.78-4.13; HR: 2.08, 95% CI: 1.57-2.74, respectively) even after adjustment for procedural success and EuroSCORE II or Society of Thoracic Surgeons Predicted Risk of Mortality. The NYHA functional class improved across all TRI-SCORE values. CONCLUSIONS: In the TriValve registry, the TRI-SCORE has a suboptimal performance in predicting clinical outcomes. However, a TRISCORE ≥8 is associated with an increased risk of clinical events and a lack of prognostic benefit after successful TTVI.

Differential effects of anaemia and iron deficiency on long-term outcomes following transcatheter edge-to-edge repair in degenerative vs. secondary mitral regurgitation: results from a large single-center study.

BACKGROUND: Anaemia and iron deficiency (ID) are independently associated with adverse outcomes in patients with cardiovascular diseases, especially in those with heart failure. Here, we aimed to clarify the long-term effect of anaemia and ID on outcomes in patients undergoing transcatheter mitral edge-to-edge repair (TEER) for relevant mitral regurgitation (MR) as well as to relate these to the underlying MR aetiology. METHODS: 833 patients (median age 77.1 years, 40.7% women, 63.3% secondary MR) treated by TEER between 09/2008 and 07/2019 were included and stratified according to baseline anaemia (hemoglobin < 12 g/dL in women and < 13 g/dL in men) or ID. RESULTS: Anaemia and ID were frequent with 61.6% and 68.1%, respectively. Anaemic patients had a lower functional status at baseline and were less likely to improve after TEER. In addition, anaemia was associated with all-cause mortality (hazard ratio [HR] = 1.68, 95% confidence interval [CI] 1.36-2.07, p < 0.001) and the composite endpoint of death or heart failure (HF) rehospitalization (HR = 1.30, 95% CI 1.10-1.54, p = 0.002). In contrast, ID was not associated with either all-cause mortality or the composite endpoint of death or HF rehospitalization. CONCLUSION: Patients undergoing TEER have high rates of both anaemia and ID. However, anaemia is associated with worse functional baseline status and post-interventional improvements compared to ID. Furthermore, anaemia is linked to higher rates of mortality and HF rehospitalization, particularly in those with secondary MR.

Transcatheter valve repair of tricuspid regurgitation with the PASCAL system: TriCLASP study 30-day results.

BACKGROUND: Severe tricuspid regurgitation (TR) is independently associated with increased morbidity and mortality. Percutaneous transcatheter approaches may offer an alternative for patients not amenable to surgery. METHODS: TriCLASP is a prospective, single-arm, multicenter European post-market clinical follow-up study (NCT04614402) to evaluate the safety and performance of the PASCAL system (Edwards Lifesciences) in patients with severe or greater TR. At 30 days, a composite of major adverse events (MAEs) adjudicated by a clinical events committee, echocardiographic parameters adjudicated by core laboratory, and clinical, functional, and quality-of-life measures were evaluated. RESULTS: Mean age of the 74 enrolled patients was 80.3 years, with 58.1% female, 90.5% systemic hypertension, and 77.0% in New York Heart Association (NYHA) class III/IV. Mean Society for Thoracic Surgeons score (MV repair) was 9.0%. TR severity was significantly reduced at discharge (p < 0.001) and sustained at 30 days (p < 0.001), and 90.0% of patients achieved ≤moderate TR. The composite MAE rate at 30 days was 3.0%, including 4 events in 2 patients: cardiovascular mortality 1.5%, stroke 1.5%, renal complications requiring unplanned dialysis or renal replacement therapy 1.5%, and severe bleeding 1.5%. There were no nonelective tricuspid valve reinterventions, major access site and vascular complications, major cardiac structural complications, or device embolizations. NYHA class I/II was achieved in 55.8%, 6-minute walk distance improved by 38.2 m (p < 0.001), and Kansas City cardiomyopathy questionnaire scores improved by 13.4 points (p < 0.001). CONCLUSION: Experience with the PASCAL transcatheter valve repair system in a European post-market setting confirms favorable safety and effectiveness at 30 days. TR significantly reduced, and clinical, functional, and quality-of-life outcomes significantly improved. This study is ongoing. Clinical Trial Registration: The study is ongoing and registered on ClinicalTrials.gov as NCT04614402. The current analysis is an interim report.

Early Clinical Experience With the TRICENTO Bicaval Valved Stent for Treatment of Symptomatic Severe Tricuspid Regurgitation: A Multicenter Registry.

BACKGROUND: Patients with severe tricuspid regurgitation present late and are often ineligible for surgery or transcatheter repair systems. Transfemoral venous implantation of a bicaval valved stent has been proposed as therapeutic option in selected patients. The aim of this study was to summarize the early procedural and clinical outcomes of the novel TRICENTO system for the treatment of patients with symptomatic severe tricuspid regurgitation. METHODS: All consecutive patients treated with the custom-made TRICENTO implant at the participating centers were included in this retrospective multicentre registry. RESULTS: A total of 21 high-risk patients (mean age 76±7 years; 67% female) with severe or higher grade tricuspid regurgitation were analyzed. The majority of the patients were in New York Heart Association class III/IV (95%), had peripheral edema (95%), and previous hospitalization for right heart failure (67%). Technical success was 100%, and there was no case of in-hospital mortality. During follow-up (median 61 days), symptomatic improvement was observed (65% in New York Heart Association class I/II; P<0.001). Computed tomography revealed asymptomatic fractures of the TRICENTO prosthesis in 3 patients. Cardiac magnetic resonance imaging obtained in 7 patients showed a significant decrease (252±65 mm3 at baseline versus 216±58 mm3 at follow-up, P=0.006) of right ventricular end-diastolic volume. The overall-survival rate was 76% at 1 year. CONCLUSIONS: The present data indicate the feasibility of transfemoral bicaval valved stent implantation for the treatment of severe tricuspid regurgitation. Functional improvement and signs of right ventricular reverse remodeling were observed. Stent fractures did not impair valve function, but require refinement of prosthesis design and careful assessment of eligibility criteria.

Transcatheter Tricuspid Valve Intervention in Patients With Previous Left Valve Surgery.

BACKGROUND: Scarce data exist on patients with previous left valve surgery (PLVS) undergoing transcatheter tricuspid valve intervention (TTVI). This study sought to investigate the procedural and early outcomes in patients with PLVS undergoing TTVI. METHODS: This was a subanalysis of the multicenter TriValve registry including 462 patients, 82 (18%) with PLVS. Data were analyzed according to the presence of PLVS in the overall cohort and in a propensity score-matched population including 51 and 115 patients with and without PLVS, respectively. RESULTS: Patients with PLVS were younger (72 ± 10 vs 78 ± 9 years; p < 0.01) and more frequently female (67.1% vs 53.2%; P = 0.02). Similar rates of procedural success (PLVS 80.5%; no-PLVS 82.1%; P = 0.73), and 30-day mortality (PLVS 2.4%, no-PLVS 3.4%; P = 0.99) were observed. After matching, there were no significant differences in both all-cause rehospitalisation (PLVS 21.1%, no-PLVS 26.5%; P = 0.60) and all-cause mortality (PLVS 9.8%, no-PLVS 6.7%; P = 0.58). At last follow-up (median 6 [interquartile range 1-12] months after the procedure), most patients (81.8%) in the PLVS group were in NYHA functional class I-II (P = 0.12 vs no-PLVS group), and TR grade was ≤ 2 in 82.6% of patients (P = 0.096 vs no-PVLS group). A poorer right ventricular function and previous heart failure hospitalization determined increased risks of procedural failure and poorer outcomes at follow-up, respectively. CONCLUSIONS: In patients with PLVS, TTVI was associated with high rates of procedural success and low early mortality. However, about one-third of patients required rehospitalisation or died at midterm follow-up. These results would support TTVI as a reasonable alternative to redo surgery in patients with PLVS and suggest the importance of earlier treatment to improve clinical outcomes.

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

OBJECTIVES: The 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. BACKGROUND: Transcatheter 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. METHODS: The 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. RESULTS: All 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). CONCLUSIONS: Concurrent 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.

Impella 5.0 therapy as a bridge-to-decision option for patients on extracorporeal life support with unclear neurological outcomes.

OBJECTIVES: Peripheral venoarterial extracorporeal life support (ECLS) for the treatment of cardiogenic shock has shown to improve survival but is associated with complications. However, if the patient cannot be weaned from ECLS, their therapy options are limited. Although durable left ventricular assist device implantation might be an option in such cases, an unclear neurological outcome is often a contraindication. We hypothesize that Impella 5.0 therapy provides sufficient circulatory support while avoiding ECLS-related complications, thereby allowing for an adequate evaluation of a patient's neurological state and facilitating further treatment options. METHODS: We retrospectively reviewed data from 22 ECLS patients (mean age 56.5 ± 10.7 years) with an unclear neurological status who underwent Impella 5.0 implantation between January 2016 and July 2018 in our institution. Neurological status was evaluated on a daily basis using the cerebral performance category score and the modified Rankin scale. RESULTS: Sixteen patients (72.7%) were resuscitated before ECLS implantation and 13 patients (59.1%) had acute myocardial infarction. The mean duration on ECLS before Impella 5.0 implantation was 9.3 ± 1.7 days. All patients were successfully weaned from ECLS by Impella 5.0 implantation via the axillary artery. The mean duration on Impella 5.0 was 16.3 ± 4.7 days. In surviving patients, both quantitative measurements of cerebral performance improved after 30 days compared to the baseline (P < 0.01). Six patients (27.3%) were bridged to a durable left ventricular assist device. In 9 patients (40.9%), myocardial function recovered during Impella 5.0 support and the device was successfully explanted. The 30-day survival rate was 68.2%. CONCLUSIONS: Impella 5.0 support provides a bridge-to-decision option for patients following ECLS implantation and leads to left ventricular unloading. It allows further evaluation of a patient's neurological situation and facilitates further therapy. About two-thirds of patients survived with acceptable neurological outcomes.

Insights from eight years of adoption experience of transcatheter mitral valve repair in Germany: observed utilisation patterns and impact on overall mitral valve procedure volumes.

AIMS: The German healthcare system was among the first to introduce transcatheter mitral valve repair (TMVR) into routine care. The objective of this study was to analyse adoption and utilisation patterns and to estimate the impact of TMVR availability on mitral valve (MV) procedure volumes in the first eight years after commercialisation. METHODS AND RESULTS: Procedure volumes were collected from German Federal Statistics Office databases for TMVR and mitral valve surgery (MVS) from 2008-2015. Procedure volumes were stratified by age group (<65, 65-74, 75-84, ≥85 years). Overall procedure volumes grew from 14,525 to 24,898 (+71%). MVS procedures grew from 14,477 to 20,402 (+41%) (p=0.008). The proportion of TMVR procedures grew from 0.3% (48 procedures) to 18.1% (4,496 procedures) (p=0.008). In 2015, TMVR use reached 5%, 15%, 31%, and 68% of overall MV procedures in the studied age groups (<65, 65-74, 75-84, ≥85 years). MVS volumes grew in all age groups, with the highest increase in the age group <65 (+2,945). CONCLUSIONS: The availability of TMVR has contributed to a pronounced increase in MV procedure volumes in Germany. Simultaneously, MVS procedure volumes continued to grow substantially. The highest increase of TMVR was observed in elderly populations, suggesting referral of patients with MV disease previously left untreated.

Comparative analysis of balloon- versus mechanically-expandable transcatheter heart valves considering landing zone calcification.

BACKGROUND: The balloon-expandable Sapien 3 (Edwards Lifesciences, Irvine, CA, USA) and the mechanically-expandable Lotus valve (Boston Scientific, Marlborough, MA, USA) are established devices for transcatheter aortic valve implantation. We sought to compare both transcatheter heart valves (THV) under consideration of the extent of THV landing zone calcification. METHODS: This retrospective analysis includes consecutive patients with severe aortic stenosis treated with Sapien 3 (S3; n=212) or Lotus (n=61) THV via transfemoral access. Outcome was assessed according to VARC II definitions. Rate of paravalvular leakage (PVL), periprocedural stroke, and permanent pacemaker implantation (PPI) was adjusted for THV landing zone calcification as calculated by multi-slice computed tomography. RESULTS: There was no difference in preoperative risk (all results as follows S3 vs. Lotus: STS-PROM 5.9±5.6% vs. 4.8±2.6%, p=0.14), rate of device success (95.3% vs. 95.1%, p=0.67), 30-day mortality (1.9% vs. 4.9%, p=0.16), periprocedural stroke (1.4% vs. 4.9%, p=0.27), and major access site complications (9.4% vs. 9.8%, p=0.93). PPI was more frequent (19.4% vs. 34.4%, p=0.01) and significant PVL was less frequent (≥mild PVL: 17.6% vs. 3.7%, p=0.04) after Lotus implantation. No association was found between landing zone calcification and periprocedural stroke rate (OR 1.19, 95%CI 0.92-1.54, p=0.17) or need for PPI (OR 1.04, 95%CI 0.91-1.18, p=0.57). The extent of landing zone calcification was associated with risk for PVL ≥mild (OR 1.21, 95%CI 1.03-1.42, p=0.02). After adjusting for landing zone calcification risk for PVL ≥mild was lower with the Lotus valve (OR 0.15, 95%CI 0.02-0.54, p=0.01). CONCLUSION: Both THVs yield comparable procedural and clinical outcomes except for a higher PPI rate with the Lotus valve, which is independent from the extent of landing zone calcification. The extent of landing zone calcification is associated with an increased risk for PVL for both THV, but is significantly reduced with the Lotus valve.

Percutaneous left atrial unloading to prevent pulmonary oedema and to facilitate ventricular recovery under extracorporeal membrane oxygenation therapy.

OBJECTIVES: Left-sided unloading during extracorporeal membrane oxygenation (ECMO) therapy is crucial to prevent pulmonary oedema and facilitate ventricular recovery. We present the case of a 55-year-old man under ECMO therapy with pre-existing left ventricular (LV) thrombus formation and in need of ventricular unloading. METHODS: We implanted a 21-Fr TandemHeart Protek Solo trans-septal cannula into the left atrium using a trans-septal approach via the femoral vein. The cannula was connected to the venous line of the ECMO circuit. A flow probe and a clamp to reduce flow, if necessary, were attached to the left atrium line. Left atrium flow was adjusted to 900 ml/min under transoesophageal echocardiography control to keep the atrial septum in the mid-line and to prevent suction of the inflow cannula. RESULTS: After 9 days, the patient was weaned step-wise from ECMO and the TandemHeart cannula, which was then explanted. The patient is in New York health Association Class II without neurological sequelae (Cerebral Performance Scale 1). After 3 months, the patient has fully recovered and is working daily. The LV function is still moderately impaired, and the size of the LV thrombus remains the same. The atrial septum shows no residual defect. CONCLUSIONS: Percutaneous trans-septal insertion of a TandemHeart cannula incorporated in an ECMO circuit for the prevention of pulmonary oedema and subsequent weaning from extracorporeal circulation was feasible and safe in a patient with cardiogenic shock and an LV thrombus.

Radiation exposure during the implantation of bioabsorbable vascular scaffolds versus drug-eluting stents in non-complex coronary lesions: a matched-cohort study.

BACKGROUND: Bioabsorbable vascular scaffolds (BVS) are a novel option for the treatment of coronary lesions in patients with stable coronary artery disease or acute coronary syndromes. We aimed to identify the influence of BVS implantation on radiation exposure and procedural outcomes compared to drug-eluting stents (DES) in daily clinical practice. METHODS: A retrospective single-center study was performed in patients undergoing percutaneous coronary intervention with BVS from 2013 to 2014. Only patients with exclusive BVS implantation (N.=78 procedures) were compared with a 2:1 matched cohort of exclusive DES-treated patients in the same period (N.=156 procedures). We used a four-step protocol to reduce radiation exposure in all procedures. Furthermore, a 12-month clinical follow-up was performed. RESULTS: Patients had similar baseline characteristics due to matching. Radiation exposure (1826 vs. 2167 cGy*cm2, P=0.673), procedure time (73 vs. 65 minutes, P=0.574), target vessel revascularization (1.3 vs. 1.3%, p=1.000 for PCI; 1.3 vs. 0.6%, P=0.616 for CABG), cardiovascular death (0.0 vs. 2.6%, P=0.304) or all-cause death (0.0 vs. 3.2%, P=0.172) were similar after implantation of BVS vs. DES. However, exposure to contrast agent (166 vs. 139 mL, P=0.028) was significantly higher in the BVS group. CONCLUSIONS: The implantation of BVS in combination with a simple four-step protocol is a feasible option for interventional treatment of non-complex coronary lesions without significant impact on radiation exposure or outcome measures in daily clinical routine.

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.

AIMS: 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. METHODS AND RESULTS: 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). CONCLUSIONS: The MitraClip implantation is feasible and safe even in high-risk patients with MR and cardiac comorbidities.

Transcatheter valve-in-valve implantation versus redo surgical aortic valve replacement in patients with failed aortic bioprostheses.

OBJECTIVES: Transcatheter aortic valve-in-valve implantation (ViV) is a new treatment for failing bioprostheses (BP) in patients with high surgical risk. However, comparative data, using standard repeat surgical aortic valve replacement (redo-SAVR), are scarce. We compared outcomes after ViV with those after conventional redo-SAVR in two European centres with established interventional programmes. METHODS: In-hospital databases were retrospectively screened for patients ≥60 years, treated for failing aortic BP. Cases of infective endocarditis or combined procedures were excluded. End-points were adjudicated according to the Valve Academic Research Consortium (VARC-2) criteria. RESULTS: From 2002 to 2015, 130 patients were treated (ViV: n = 71, redo-SAVR: n = 59). Age and logistic EuroSCORE I scores were higher with ViV (78.6 ± 7.5 vs 72.9 ± 6.6 years, P < 0.01; 25.1 ± 18.9 vs 16.8 ± 9.3%, P < 0.01). The 30-day mortality rate was not significantly different (4.2 and 5.1%, respectively) (P = 1.0). Device success was achieved in 52.1% (ViV) and 91.5% (P < 0.01). No stroke was observed after ViV but in 3.4% after redo-SAVR (P = 0.2). Intensive care stay was longer after redo-SAVR (3.4 ± 2.9 vs 2.0 ± 1.8 days, P < 0.01). Mean transvalvular gradients were higher post-ViV (19.7 ± 7.7 vs12.2 ± 5.7 mmHg, P < 0.01), whereas the rate of permanent pacemaker implantation was lower (9.9 vs 25.4%, P < 0.01). Survival rates at 90 and180 days were 94.2 and 92.3% vs 92.8 and 92.8% (P = 0.87), respectively. CONCLUSIONS: Despite a higher risk profile in the ViV group, early mortality rates were not different compared with those of surgery. Although ViV resulted in elevated transvalvular gradients and therefore a lower rate of device success, mortality rates were similar to those with redo-SAVR. At present, both techniques serve as complementary approaches, and allow individualized patient care with excellent outcomes.

Critical evaluation of the MitraClip system in the management of mitral regurgitation.

The MitraClip (MC) system is a device for percutaneous, transseptal edge-to-edge reconstruction of the mitral valve (MV) in patients with severe mitral regurgitation (MR) not eligible for surgery. Recently, a number of studies have underlined the therapeutic benefit of the MC system for patients with extreme and high risk for MV surgery suffering from either degenerative or functional MR. The MC procedure shows negligible intraprocedural mortality, low periprocedural complication rates, and a significant reduction in MR, as well as an improvement in functional capacity and most importantly quality of life. Presently, the MC system has become an additional interventional tool in the concert of surgical methods. It hereby enlarges the spectrum of MV repair for the Heart Team. Lately, many reviews focused on the MC system. The current review describes the developments in the treatment of MR with the MC system.

First-in-man treatment of a degenerated mitral surgical valve with the mechanical expanding Lotus™ valve.

Percutaneous placement of transcatheter heart valves for treatment of degenerated surgical valves in the aortic and mitral position is an emerging therapy for selected high-risk patients. Here we describe in detail the first case in the literature of a patient (female, 72 years old, log EuroSCORE 22.9%) with a degenerated biological mitral prosthesis which was successfully treated by transapical implantation of a Lotus valve. The case described demonstrates the very controlled feasibility of valve-in-valve treatment for a degenerated mitral bioprosthesis with a mechanically expanding Lotus valve.

One-year outcomes and predictors of mortality after MitraClip therapy in contemporary clinical practice: results from the German transcatheter mitral valve interventions registry.

AIMS: The transcatheter mitral valve interventions (TRAMI) registry was established in order to assess safety and efficacy of catheter-based mitral valve interventional techniques in Germany, and prospectively enrolled 828 MitraClip patients (median age 76 years, median log. EuroSCORE I 20.0%) between August 2010 and July 2013. We present the 1-year outcome in this MitraClip cohort-which is the largest published to date. METHODS AND RESULTS: Seven forty-nine patients (90.5%) were available for 1-year follow-up and included in the following analyses. Mortality, major adverse cardiovascular event rates, and New York Heart Association (NYHA) classes were recorded. Predictors of 1-year mortality were identified by multivariate analysis using a Cox regression model with stepwise forward selection. The 1-year mortality was 20.3%. At 1 year, 63.3% of TRAMI patients pertained to NYHA functional classes I or II (compared with 11.0% at baseline), and self-rated health status (on EuroQuol visual analogue scale) also improved significantly by 10 points. Importantly, a significant proportion of patients regained the complete independence in self-care after MitraClip implantation (independence in 74.0 vs. 58.6% at baseline, P = 0.005). Predictors of 1-year mortality were NYHA class IV (hazard ratio, HR 1.62, P = 0.02), anaemia (HR 2.44, P = 0.02), previous aortic valve intervention (HR 2.12, P = 0.002), serum creatinine ≥1.5 mg/dL (HR 1.77, P = 0.002), peripheral artery disease (HR 2.12, P = 0.0003), left ventricular ejection fraction <30% (HR 1.58, P = 0.01), severe tricuspid regurgitation (HR 1.84, P = 0.003), and procedural failure (defined as operator-reported failure, conversion to surgery, failure of clip placement, or residual post-procedural severe mitral regurgitation) (HR 4.36, P < 0.0001). CONCLUSIONS: Treatment of significant MR with MitraClip resulted in significant clinical improvements in a high proportion of TRAMI patients after 12 months. In the TRAMI cohort, the failure of procedural success exhibited the highest hazard ratio concerning the prediction of 1-year mortality.

MitraClip-data analysis of contemporary literature.

Treatment of mitral regurgitation (MR) with the MitraClip (MC), a percutaneous, transseptal edge-to-edge reconstruction of the mitral valve, has become an interesting treatment option in most patients not eligible for surgery. Lately a variety of studies have been published analyzing the treatment of MR with the MC in degenerative as well as functional MR. The results for both entities of MR show negligible intraprocedural mortality, low periprocedural complications rates and a beneficiary outcome in terms of reduction in MR as well as an improvement in functional capacity and quality of life. Here we summarize the latest results focusing on safety and efficacy of MC treatment.

Transcatheter valve-in-valve therapy using 6 different devices in 4 anatomic positions: Clinical outcomes and technical considerations.

OBJECTIVES: Transcatheter valve-in-valve implantation (ViV) is emerging as a novel treatment option for patients with deteriorated bioprostheses. We report our cumulative experience using 6 types of transcatheter heart valves (THVs) in all anatomic positions. METHODS: Seventy-five consecutive patients (74.1 ± 12.9 years, 50.7% male (38/75), logEuroSCORE I 26.2% ± 17.8%, STS-PROM 8.8% ± 7.4%) receiving ViV procedures from 2008 to 2014 were included for analysis. Data were prospectively gathered and retrospectively analyzed. RESULTS: ViV was performed in aortic (72.0%, 54/75), mitral (22.7%, 17/75), tricuspid (2.7%, 2/75), and pulmonary (2.7%, 2/75) positions. THVs used were Edwards SAPIEN (XT)/SAPIEN3 (52.0%, 39/75), Medtronic Core Valve/Core Valve Evolut(R) (34.7%, 26/75), St Jude Portico (4.0%, 3/75), Boston Scientific Lotus (4.0%, 3/75), Jena Valve (2.7%, 2/75), and Medtronic Engager (2.7%, 2/75). Interval from index procedure to ViV was 9.3 ± 4.9 years. Access was transapical in 53.3% (40/75), transfemoral (transarterial or transvenous) in 42.7% (32/75), transaortic in 2.7% (2/75), and transjugular in 1.3% (1/75). ViV was successful in 97.3% (73/75) with 2 patients requiring sequential THV implantation for initial malpositioning. Overall immediate procedural (≤72 hours) and all-cause 30-day mortality were 2.7% (2/75) and 8.0% (6/75). Corresponding values after aortic ViV were 1.9% (1/54) and 5.6% (3/54). No periprocedural strokes or cases of coronary obstruction occurred. Paravalvular leakage was less than or equal to mild in all cases. After aortic ViV, gradients were max/mean 34.1 ± 14.2/20.1 ± 7.1 mm Hg and effective orifice area (EOA) was 1.5 ± 1.4 cm(2). Corresponding values after mitral ViV were gradients max/mean 14.2 ± 8.2/4.7 ± 3.1 mm Hg and EOA 2.4 ± 0.9 cm(2). CONCLUSIONS: ViV can be performed in all anatomic positions with acceptable hemodynamic and clinical outcome in high-risk patients. Increasing importance of ViV can be anticipated considering growing use of surgical bioprostheses.

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

AIMS: To investigate the influence of non-cardiac comorbidities on outcomes of patients enrolled in the German transcatheter mitral valve interventions (TRAMI) registry. METHODS AND RESULTS: 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 30 days. Renal insufficiency was the only non-cardiac comorbidity which was independently associated with the 30-day MACCE rate. CONCLUSIONS: 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.

Reducing radiation exposure during invasive coronary angiography and percutaneous coronary interventions implementing a simple four-step protocol.

BACKGROUND: With an increasing number of complex and repeated percutaneous coronary interventions (PCI), radiation-induced hazards for patients and operators remain an important issue in fluoroscopy-guided procedures. Our objective was to evaluate radiation exposure during coronary angiographic procedures and assess the efficacy of a four-step program to reduce radiation exposure during coronary angiography (CAG) and PCI. METHODS AND RESULTS: A retrospective single-center analysis was performed in patients undergoing CAG or PCI in the first 6 months of 2012 vs. the first 6 months of 2014 (n = 3,107 procedures). During 2013, a four-step protocol was established in our hospital. It contained measures to reduce radiation exposure, including a frame rate reduction from 15 to 7.5 frames per second, the use of fluoroscopy storage, strict use of beam collimation, and repeat training on radiation safety. After adjustment for confounding variables, a dose-area product (DAP) reduction of 54.2% was observed subsequent to implementation of the four-step protocol. Independent predictors of DAP were age [odds ratio (OR) 1.01], body surface area (OR 5.47), prior coronary artery bypass grafting (OR 1.44), radial access (OR 1.16), PCI (OR 2.36), female gender (OR 0.91), and the implementation of the four-step program (OR 0.46). CONCLUSION: A simple four-step protocol led to a significant reduction in radiation exposure in diagnostic and interventional coronary procedures without significant drawbacks in image quality. Hence, radiation safety programs are of paramount importance and should be established to improve patient and operator safety with regard to radiation-induced hazards.