Background Evidence regarding favorable treatment of patients with functional mitral regurgitation (FMR) using transcatheter edge-to-edge repair (TEER) is constantly growing. However, there is only few data directly comparing TEER and surgical mitral valve repair (SMVr). Aims To compare baseline characteristics, short-term and 1-year outcomes in FMR patients undergoing mitral valve (MV) TEER or SMVr using a meta-analytic approach. Methods Systematic database search identified 1,703 studies reporting on TEER or SMVr for treatment of FMR between January 2010 and December 2020. A meta-analytic approach was used to compare outcomes from single-arm and randomized studies based on measures by means of their corresponding 95% confidence intervals (CI). Statistical significance was assumed if CIs did not overlap. A total of 21 TEER and 37 SMVr studies comprising 4,304 and 3,983 patients were included. Results Patients in the TEER cohort presented with higher age (72.0 ± 1.7 vs. 64.7 ± 4.7 years, p < 0.001), greater burden of comorbidities like hypertension ( p < 0.001), atrial fibrillation ( p < 0.001), lung disease ( p < 0.001) and chronic renal disease ( p = 0.005) as well as poorer left ventricular ejection fraction (30.9 ± 5.7 vs. 36.6 ± 5.3%, p < 0.001). In-hospital mortality was significantly lower with TEER [3% (95%-CI 0.02–0.03) vs. 5% (95%-CI 0.04–0.07)] and 1-year mortality did not differ significantly [18% (95%-CI 0.15–0.21) vs. 11% (0.07–0.18)]. NYHA [1.06 (95%-CI 0.87–1.26) vs. 1.15 (0.74–1.56)] and MR reduction [1.74 (95%-CI 1.52–1.97) vs. 2.08 (1.57–2.59)] were comparable between both cohorts. Conclusion Despite considerably higher age and comorbidity burden, in-hospital mortality was significantly lower in FMR patients treated with TEER, whereas a tendency toward increased 1-year mortality was observed in this high-risk population. In terms of functional status and MR grade reduction, comparable 1-year results were achieved.
Abstract Background Mitral regurgitation (MR) and tricuspid regurgitation (TR) often occur simultaneously and symptoms of biventricular heart failure can overlap. There is currently no consensus on the management of combined MR and TR. Purpose To evaluate the impact of TR on echocardiographic and functional outcome after M-TEER. Methods 740 patients underwent M-TEER for moderate-to-severe MR at our center from 2010 to 2021. Patients were analyzed according to severity of concomitant TR: low-grade TR (grade ≤ I (trace - mild)), moderate TR (grade II) and high-grade TR (grade III - V (severe - torrential)). After M-TEER, patients were followed up for 12 months and their echocardiographic and functional outcome was evaluated. Results Low-grade TR was present in 279 patients (37.7%), moderate TR in 170 patients (23.0%) and high-grade TR in 291 patients (39.3%) at the time of M-TEER procedure. Patients with moderate to high-grade TR had higher morbidity resulting in higher EuroSCORE II and STS-Score. At baseline more patients had MR grade ≥III in the high-grade TR group (92.8% vs. 87.1% in the low-grade TR group; p=0.023). Procedural success of M-TEER was achieved similarly in all groups (98.2% vs. 97.6% vs. 95.9%, p=0.22). At discharge 87.6% of patients with low-grade TR and 80.9% of patients with high-grade TR had residual MR grade ≤I (p=0.036). Residual MR grade ≥III was present in 6.0% of low-grade TR patients and 10.5% of high-grade TR patients at discharge (p=0.062). 3 months after M-TEER residual MR ≥III increased to 9.4% vs. 13.4% (p=0.23) and after 12 months further increased to 12.3% vs. 15.3%, respectively (p=0.52). TR grade decreased rapidly and consistently after M-TEER. 3 months after the procedure only 48.0% of high-grade TR patients still had TR grade ≥III (p<0.001). After 12 months this proportion declined to 46.8% (p=0.99). High-grade TR patients had significantly higher mortality (21.5% vs. 18.2% vs. 11.1%, p=0.003) up to 12 months after M-TEER. However, TR-grade ≥III did not independently predict mortality (HR 1.326, 95% CI 0.623–2.824, p=0.46). Conclusion M-TEER patients with concomitant moderate to high-grade TR had higher morbidity at baseline compared to low-grade TR patients. M-TEER was safe and effective in MR reduction independent of concomitant TR severity. However, high-grade TR patients had an increased risk for mortality after M-TEER, but high-grade TR did not independently predict adverse outcome. After M-TEER TR grade decreased rapidly and significantly in the high-grade TR group. Funding Acknowledgement Type of funding sources: None.
Abstract Background The MitraClip is the worldwide established transcatheter edge-to-edge repair system with over 100,000 treated patients. The recently approved PASCAL repair system is well adopted in the field of percutaneous mitral regurgitation (MR) treatment with growing acceptance both in mitral and tricuspid valves. The aim of this retrospective multicenter study was to compare the Edwards' PASCAL System with the Abbott MitraClip System in terms of procedural results and short-term outcome. Methods We retrospectively evaluated patient data of three high volume German centers that performed percutaneous edge to edge procedures either with the MitraClip or the PASCAL repair system. Primary endpoint was the amount of MR reduction. Secondary endpoints were residual MR at discharge, technical success, device success and 30-day mortality. Results Between 2018 and 2020 a total of 412 procedures were performed in the three centers. 216 cases were performed with the MitraClip compared to 196 procedures done with the PASCAL repair system. Patients were male in 55.6% of the cases (50.5% in the MitraClip cohort compared to 61.2% in the PASCAL cohort, p=0.028), mean Logistic Euro-Score II was 4.42 (3.58 in the MitraClip and 3.23 in the PASCAL cohort, p=0.038) and reduced LVEF beyond 45% was seen in 42.6% of the cases (49.5% in the MitraClip compared to 35.3% in the PASCAL cohort, p=0.004). Severe MR at baseline was seen in 98.5% in the MitraClip cohort compared to 98.6% in the PASCAL cohort, p=0.909). Mean number of implanted devices was 1.41±0.56 in the MitraClip cohort and 1.37±0.55 in the PASCAL cohort (p=0.401). Procedures were successfully conducted with both edge-to-edge systems (device success rate 93.2% in the MitraClip cohort and 94.0% in the PASCAL cohort, p=0.775), leading to comparably good results (final MR ≤2 in 94.4% with the MitraClip compared to 95.9% with the PASCAL system, p=0.448) and very good results (final MR ≤1 in 72.6% in the MitraClip compared to 79.5% in the PASCAL cohort, p=0.102). After propensity score matching for adjustment of major differences among the two treatment strategies (including age, gender, MR etiology, EROA, Severe MR (III and IV), reduced LVEF and Mitral Valve orifice area) the achieved mean MR reduction remains comparable (2.29±0.82 with the MitraClip compared to 2.46±0.82 with the PASCAL system, p=0.191). In multivariate regression analysis STS Score independently correlates with a very good final result while device choice did not show a significant impact in this cohort. Conclusion In this retrospective multicenter study both the MitraClip and PASCAL system performed excellent with comparable procedural success rates. Achieved final average reduction of MR Grade was 2.29±0.82 with the MitraClip and 2.46±0.82 with the PASCAL system. Funding Acknowledgement Type of funding sources: None.
Background: During the ongoing SARS-CoV-2 pandemic, a significant decline in acute coronary syndromes (ACS) including ST segment elevation myocardial infarction (STEMI) has been reported from several countries. Studies on the effect of the pandemic itself and measures of social restriction on clinical presentation and outcome of STEMI patients are contradictive. Methods: 103 consecutive STEMI patients admitted to our clinic between November 21st, 2019 and May 20th, 2020 were divided into a pre-pandemic cohort (62 patients, November 21st -March 20th, 2020), and a pandemic cohort (41 patients, March 21st - May 20th, 2020). Clinical presentation, in-hospital complications, outcome, laboratory data, and procedural characteristics of acute percutaneous coronary interventions (PCI) between the cohorts were compared. Results: Compared to the pre-pandemic period patients in the pandemic cohort had higher peak high sensitivity troponin T (2903ng/l, interquartile range {IQR} 9->10000ng/l vs. 3967ng/l, IQR 289->10000ng/l, p=0.04), more often a TIMI flow <3 at the end of the revascularization procedure (8% vs. 34%, p<0.01), were more often treated with tirofiban (3% vs. 29%, p<0.01), stayed longer on ICU (1.06 vs. 2.39 days, p=0.02), and had more in-hospital complications (16% vs. 39%, p=0.01). Conclusion: Presumably due to a delay in seeking acute medical care during the SARS-CoV-2 pandemic, patients with STEMI presented with higher troponin, worse restoration of coronary flow after acute PCI and suffered from more in-hospital complications compared to previous months. Public awareness for life-threatening diseases such as ACS has to be maintained to ensure adequate medical care for all patients during the SARS-CoV-2 pandemic.
Abstract Background Tricuspid regurgitation (TR) is associated with high morbidity and mortality, but many patients are ineligible for surgical treatment due to age and co-morbidities. As a consequence, transcatheter treatment techniques have evolved over the last years. Leaflet repair is one of the most commonly used techniques and has recently gained commercial approval for dedicated TR treatment. The device offers the possibility for independent leaflet grasping and a central spacer can bridge larger coaptation gaps. The hitherto evidence is mainly based on compassionate use data. This is the first report on commercial use in a multicenter study with a large patient cohort and long-term follow-up. Purpose To investigate safety and efficacy of the leaflet repair system in the treatment of TR in a commercial use setting. Methods We retrospectively collected clinical and imaging data from all consecutive patients undergoing leaflet repair for TR at four tertiary care centres. A core laboratory analysis of the echocardiographic data has been performed. Baseline, procedural and follow-up data has been included in the analysis. Results A total of 155 patients, treated between February 2019 and February 2021 has been included (mean age 77±8 years, 52% female). Mean STS score was 7.7±6.7%. TR was of functional etiology in the majority (82%) of patients and was severe or higher graded in 87% (mean EROA 68±47 mm2). Patients were highly symptomatic with exertional dyspnea NYHA functional class III/IV in 91%. Technical success was achieved in 97% and TR was successfully reduced to ≤2+ in 90% of patients (p<0.001). Three cases of intra-procedural single-leaflet device attachment (SLDA) occurred, and there was one case of access site bleeding requiring emergency surgery. There were no other in-hospital adverse events. Follow-up was available for 120 patients (median follow-up 182, IQR 54–356 days). TR reduction was sustained in most patients with TR ≤2+ in 83% (p<0.001). We found indications for right ventricular (RV) remodeling with a significant decrease of RV end-diastolic diameter (57±8 mm vs. 52±10 m, p<0.001). Dimensions of the inferior vena cava decreased significantly as a sign of less congestion (27±8 mm vs. 23±7 mm, p=0.004). During the follow-up period, 15 patients (10%) died, of which 7 (5%) were of a cardiovascular cause. Symptomatic improvement was significant with 66% of patients in NYHA functional class I or II at follow-up (p<0.001) and an improvement of the 6-meter walking distance (228±120 m vs. 276±121 m, p=0.001). Conclusion Transcatheter treatment of TR with the leaflet repair system is feasible and safe. According to our data, technical success rate is high and procedural complications are rare. Patients experienced significant symptomatic improvement at follow-up with echocardiographic sustained TR reduction. Furthermore, there are indications for RV remodeling and reduced congestion. Funding Acknowledgement Type of funding sources: None. Improving valve function and symptoms
Background In patients at increased surgical risk, transcatheter edge-to-edge mitral valve repair by MitraClip implantation for severe mitral regurgitation (MR) has proven to relieve symptoms of MR, reduce New York Heart Association (NYHA) functional class and improve quality of life. Rehospitalization for decompensated heart failure occurs frequently after MitraClip implantation, negatively impacting quality of life. We aimed here to determine predictors of 1-year rehospitalization for decompensated heart failure. Methods and results A total of 355 consecutive patients who underwent MitraClip implantation at our centre were evaluated for their baseline and procedural characteristics, peri-procedural outcome and clinical endpoints. Rate of rehospitalization for decompensated heart failure was reduced from 52.7% (n = 187) in the year before MitraClip procedure to 18.0% (n = 64) (P < 0.0001) in the first year after MitraClip implantation. The mean duration until rehospitalization was 117 days after MitraClip implantation. Multivariate Cox proportional hazards regression analysis identified baseline left ventricular ejection fraction (P = 0.020), baseline troponin T (P = 0.003) and pre-procedural NYHA class (P = 0.020) as independent predictors for 1-year rehospitalization after MitraClip implantation. Rehospitalization correlated significantly with all-cause mortality (odds ratio 2.3, 95% confidence interval 1.3-4.1; P = 0.004) and cardiovascular mortality (odds ratio 3.3, 95% confidence interval 1.7-6.1; P = 0.0003). Conclusion After MitraClip implantation, annual rate of rehospitalization for decompensated heart failure was reduced by 65.8%. Baseline left ventricular ejection fraction, baseline troponin T and pre-procedural NYHA functional class are independent predictors for rehospitalization within the first year after MitraClip implantation. Patients readmitted for decompensated heart failure after MitraClip implantation had a 2.3-fold increased risk of all-cause mortality and a 3.3-fold increased risk of cardiovascular mortality compared to patients not requiring rehospitalization.
Die ostiale Läsion ist definiert als eine ostiumnahe (≤3 mm) Läsion und zeichnet sich durch eine rigide fibrotische Beschaffenheit mit z. T. ausgeprägter Verkalkung sowie einer erheblichen Neigung zum Recoil aus. Dies kann unter Umständen zu einem bescheidenen interventionellen Primärergebnis bei einer höheren Komplikationsrate und insbesondere einer höheren Restenoserate führen. Vor allem ostiale Läsionen der rechten Kranzarterie stellen eine größere interventionelle Herausforderung dar und zeigen trotz Einführung verschiedener Techniken eine erhöhte Restenoserate. Dagegen zeigen ostiale Hauptstammstenosen sehr gute Resultate nach perkutaner Intervention und Implantation von „Drug-eluting“-Stents. Die Indikation zur perkutanen transluminalen koronaren Angioplastie (PTCA) einer ostialen Läsion entspricht der Indikation zur Behandlung aller anderen Läsionen. Der Artikel gibt eine Übersicht über die Erfahrungen und Empfehlungen bezüglich der Diagnostik und interventionellen Therapie ostialer Läsionen.
An ostial lesion is defined as a lesion near to the ostium (≤3 mm) and is characterized by a rigid fibrotic texture with pronounced sclerosis associated with a very high tendency to recoil. Under certain circumstances this may lead to a modest primary interventional result accompanied by a higher complication rate and in particular a higher rate of restenosis. Ostial lesions of the right coronary artery in particular represent a greater challenge for percutaneous interventions with a higher rate of restenosis despite the introduction of various new techniques. In contrast ostial stenosis of the left main trunk shows very good results after percutaneous interventions and implantation of drug-eluting stents. The indications for percutaneous transluminal coronary angioplasty (PTCA) of an ostial lesion correspond to the indications for treatment of all other lesions. The article gives an overview of the experiences and recommendations with respect to the diagnostics and interventional therapy of ostial lesions.
Die Puls Transit Zeit (PTT) wird als Marker für Blutdruckveränderungen und Gefäßsteifigkeit betrachtet. Ebenso könnte die pPTT der Beurteilung von pulmonalen Gefäßveränderungen bei PH dienen und könnte möglicherweise nicht-invasiv mittels Doppler-Echocardiografie gemessen werden.
Purpose: True CTOs are defined by a thrombolysis in myocardial infarction flow 0 and duration of the occlusion of more than 3 months. In those lesions, successful recanalization reduced angina pain. We used cardiac magnetic resonance imaging (cMRI) to evaluate the effect of successful true CTO recanalization on left ventricular (LV) function and regional wall motion. Methods: Gadolinium contrast enhanced cMRI was performed on a 1.5 Tesla scanner in 43 patients who underwent successful recanalization of a true CTO in a native coronary artery by percutaneous coronary angioplasty. CMRI was performed prior to recanalization and repeated after 6 months. CTO was located in LAD (N=16, 37.2%), CX artery (N=9, 20.9%) or RCA (N=18, 41.9%). After successful balloon dilation drug-eluting stents with a mean stent length of 78.6±43.8mm (range 18-188mm) were implanted. In the cMRI short-axis views were split according to the 17-Segment model of the American Heart Association. For each segment the wall thickness (WT) was measured over the duration of one heart cycle and segmental WT (SWT) was calculated using the Formula SWT=(WTmax-WTmin)/WTmin. Results: In the total population cMRI showed a non-significant increase in LV ejection fraction (LVEF), as well as non-significant decreases in LV enddiastolic and endsystolic volumes. Improvement in LVEF (Δ+4.1%) was seven times higher in patients with a LVEF below the median compared with patients with a LVEF above the median (Δ+0.6%) at baseline CMRI (p<0.001). Improvement in LVEF in patients without scar tissue (Δ+3.2%) was higher than in patients with scar tissue (Δ+0.7%, p=0.029) in the target myocardium. 231 (33.5%) myocardial segments were located in the perfusion territories of the target vessel. SWT improved in all target segments significantly from 73.3±36.0% to 78.6±40.5% (p=0.008). Dysfunctional segments \[SWT<45% at baseline\] (N=58, 25.1%) showed a greater improvement in SWT (Δ+13.3%) than functional segments (Δ+2.7%, p=0.021). Segments without scar tissue (N=92) showed a significant improvement in SWT (Δ+9.2%, p=0.004). The greatest benefit of revascularisation on SWT was found in dysfunctional segments without scar tissue present (N=17, 7.4%, SWT Δ+16.6%, p=0.017). Conclusions: Successful recanalization of true CTOs in native coronary arteries is associated with a significant improvement of LVEF in patients with low baseline LVEF as well as in patients without scar tissue in the perfusion territory. Furthermore, successful true CTO recanalization is associated with a significant increase in segmental wall thickening in dysfunction segments without scar tissue.