Current status of antithrombotic therapy and in-hospital outcomes in patients with atrial fibrillation undergoing percutaneous coronary intervention in Germany.

BACKGROUND: Little is known about current patterns of antithrombotic therapy in patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI) in clinical practice in Germany. METHODS: The RIVA-PCI is a prospective, non-interventional, multicenter study with follow-up until hospital discharge including consecutive patients with AF undergoing PCI. RESULTS: Between January 2018 and March 2020, 1636 patients (elective in 52.6%, non-ST elevation acute coronary syndrome [NSTE-ACS] in 39.3%, ST-elevation myocardial infarction in 8.2%) from 51 German hospitals were enrolled in the study. After PCI a dual antithrombotic therapy (DAT) consisting of OAC and a P2Y12 inhibitor was given to 66.0%, triple antithrombotic therapy (TAT) to 26.0%, dual antiplatelet therapy to 5.5%, and a mono-therapy to 2.5% of the patients. Non-vitamin K antagonist oral anticoagulants (NOACs) were given to 82.4% and vitamin K antagonists to 11.5% of the patients. In-hospital events included death in 12 cases (0.7%), myocardial infarction, stent thrombosis, and ischemic stroke in four (0.2%) patients each, while 2.8% of patients had bleeding complications. The recommended durations for DAT or TAT at discharge were 1 month (1.5%), 3 months (2.1%), 6 months (43.1%), and 12 months (45.6%), with a 6-month course of DAT (47.7%) most often recommended after elective PCI and a 12-month course of DAT (40.1%) after ACS. CONCLUSION: The preferred therapy after PCI in patients with AF is DAT with a NOAC and clopidogrel. In-hospital ischemic and bleeding events were rare. The recommended durations for combination therapy vary considerably.

High-sensitivity cardiac troponin I after coronary artery bypass grafting for post-operative decision-making.

AIMS: Current troponin cut-offs suggested for the post-operative workup of patients following coronary artery bypass graft (CABG) surgery are based on studies using non-high-sensitive troponin assays or are arbitrarily chosen. We aimed to identify an optimal cut-off and timing for a proprietary high-sensitivity cardiac troponin I (hs-cTnI) assay to facilitate post-operative clinical decision-making. METHODS AND RESULTS: We performed a retrospective analysis of all patients undergoing elective isolated CABG at our centre between January 2013 and May 2019. Of 4684 consecutive patients, 161 patients (3.48%) underwent invasive coronary angiography after surgery, of whom 86 patients (53.4%) underwent repeat revascularization. We found an optimal cut-off value for peak hs-cTnI of >13 000 ng/L [>500× the upper reference limit (URL)] to be significantly associated with repeat revascularization within 48 h after surgery, which was internally validated through random repeated sampling with 1000 iterations. The same cut-off also predicted 30-day major adverse cardiovascular events and all-cause mortality after a median follow-up of 3.1 years, which was validated in an external cohort. A decision tree analysis of serial hs-cTnI measurements showed no added benefit of hs-cTnI measurements in patients with electrocardiographic or echocardiographic abnormalities or haemodynamic instability. Likewise, early post-operative hs-cTnI elevations had a low yield for clinical decision-making and only later elevations (at 12-16 h post-operatively) using a threshold of 8000 ng/L (307× URL) were significantly associated with repeat revascularization with an area under the curve of 0.92 (95% confidence interval 0.88-0.95). CONCLUSION: Our data suggest that for hs-cTnI, higher cut-offs than currently recommended should be used in the post-operative management of patients following CABG.

Final 3-year clinical outcomes following transcatheter aortic valve implantation with a supra-annular self-expanding repositionable valve in a real-world setting: Results from the multicenter FORWARD study.

OBJECTIVES: The Evolut R FORWARD study confirmed safety and effectivenesss of the Evolut R THV in routine clinical practice out to 1 year. Herein, we report the final 3-year clinical follow up of the FORWARD study. BACKGROUND: Transcatheter aortic valve replacement (TAVR) is a proven alternative to surgery in elderly patients with symptomatic severe aortic stenosis. Long-term clinical outcome data with the Evolut R platform are scarce. METHODS: FORWARD is a prospective multicenter observational study that evaluated the Evolut R system in routine clinical practice at 53 centres. Eligible patients had symptomatic native aortic valve stenosis or failed surgical aortic bioprosthesis and elevated operative risk per Heart-Team assessment. TAVR was attempted in 1039 patients. RESULTS: Mean age was 81.8 ± 6.2 years, 64.9% were women, STS score was 5.5 ± 4.5% and 34.2% were frail. Rates of all-cause mortality and disabling stroke were 24.8% and 4.8% at 3 years. Early need for a new pacemaker implantation after TAVR (all-cause mortality: with new PPI; 21.0% vs. without; 22.8%, p = 0.55) and the presence of > trace paravalvular regurgitation (all-cause mortality: no or trace; 22.0% vs. ≥ mild; 25.5%, p = 0.29) did not affect survival. Between 1 and 3 years incidence rates of valve related intervention, endocarditis and clinically relevant valve thrombosis were low. CONCLUSIONS: The Evolut R valve maintained a favorable safety profile through 3 years in routine clinical practice. Rates of transcatheter heart valve-related adverse events were low.

Outcomes of left main revascularization in patients with acute coronary syndromes and stable ischemic heart disease: Analysis from the EXCEL trial.

BACKGROUND: Prompt revascularization is often required in acute coronary syndromes (ACS), whereas stable ischemic heart disease (SIHD) may allow for more measured procedural planning. Whether the acuity of presentation preferentially affects outcomes after coronary artery bypass grafting (CABG) versus percutaneous coronary intervention (PCI) in patients with left main coronary artery disease (LMCAD) is unknown. We investigated whether the acuity of presentation discriminated patients who derived a differential benefit from PCI versus CABG in the randomized Evaluation of XIENCE versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization (EXCEL) trial. METHODS: We used multivariable Cox models to assess the interaction between the acuity of presentation, type of revascularization and outcomes in patients with low or intermediate SYNTAX scores enrolled in EXCEL. RESULTS: At baseline, 1151 patients (60.7%) presented with SIHD and 746 patients (39.3%) presented with an ACS. The acuity of presentation was not associated with the primary endpoint of all-cause death, MI, or stroke at 3 years (multivariable adjusted hazard ratio [HR] 0.94; 95% CI 0.70-1.26, P = .64). The primary endpoint rate was similar in patients assigned to PCI versus CABG whether they presented with SIHD (adjusted HR 1.04; 95% CI 0.73-1.48]) or with ACS (HR 0.82; 95% CI 0.54-1.26) (Pinteraction = .34). CONCLUSIONS: The acuity of presentation did not predict outcomes in patients with LMCAD undergoing revascularization, nor did it discriminate patients who derive greater event-free survival from PCI versus CABG.

Valve-in-valve transcatheter aortic valve implantation with CoreValve/Evolut R© for degenerated small versus bigger bioprostheses.

OBJECTIVES: We present our single center experience with Medtronic CoreValve and Evolut R regarding procedural outcome and 3 years follow-up in patients with degenerated bioprostheses. METHODS: From 1645 patients who underwent transfemoral TAVI at our institution between February 2009 and December 2016, 37 patients with degenerated bioprosthesis were treated with Medtronic CoreValve/Evolut R. All data concerning baseline characteristic, procedural outcomes and follow-up were entered into a dedicated database. RESULTS: Mean age was 83.9 ± 4.4 years and patients showed an average logistic EuroSCORE of 33.2 ± 16.7%. Successful ViV deployment was achieved in all cases, a permanent pacemaker was implanted in 16.2%, no periinterventional stroke and no coronary obstruction occurred. Mortality at 30 days was 2.7%, at 1-year follow-up 5.7% and at three years 13.5%. Depending on bioprosthesis size <23 mm versus ≥23 mm echocardiographic mean gradients post implantation were significantly higher in the smaller bioprostheses, 22.8 mmHg ± 9.4 mmHg versus 15.1 ± 7.1, P = 0.013. CONCLUSION: ViV-TAVI with CoreValve/R is demonstrated to be safe and effective in terms of no coronary obstruction and very low mortality up to 3 years despite slightly higher mean transprosthetic gradients especially in very small bioprostheses.

Impact of procedure-related conduction disturbances after transcatheter aortic valve implantation on myocardial performance and survival evaluated by conventional and speckle tracking echocardiography.

OBJECTIVES: Although procedure-related new cardiac conduction disturbances (CCDs) remain an important issue in transcatheter aortic valve implantation (TAVI), their effect on myocardial function and overall patient outcome remains unclear. The goal of this study was to analyze the influence of procedure-related CCDs on systolic and diastolic LV performance and on patient survival after TAVI. METHODS AND RESULTS: Ninety-five patients who underwent TAVI for severe symptomatic aortic stenosis (AS) and had a complete follow-up were evaluated with respect to procedure-related CCDs. Left ventricular (LV) performance was measured using standard echocardiographic parameters and speckle tracking analysis. Survival was assessed during longer-term follow-up (mean: 29.1 ± 16.9 months). After TAVI, the improvement of global LV function expressed as ejection fraction (LVEF; from 45.5 ± 10.0 to 47.8 ± 13.9%, P = .13) was not significant. New CCDs were found in 35.7% of TAVI recipients. A comparison between patients with and without new CCDs showed that LV systolic function improved in those without CCDs, while it tended to deteriorate in patients with CCDs (change in LVEF: 5.5 ± 12.3% vs -4.9% ± 11.5%, P = .001; change in global longitudinal strain (GLS): -1.1 ± 4.6% vs 1.2 ± 4.5%, P = .01). Changes in diastolic function did not differ significantly between the groups (changes in transmitral E/A-ratio: -0.3 ± 0.6 vs -0.5 ± 0.5, P = .1). Kaplan-Meier survival analysis revealed no significant differences between the two cohorts (P = .795). CONCLUSION: Procedure-related conduction abnormalities after TAVI lead to an LBBB-related dyssynchrony with impairment of LV performance but not of overall survival.

Transcatheter Aortic Valve Implantation in Nonagenarians: Procedural Outcome and Mid-Term Results.

BACKGROUND: For nonagenarians with symptomatic severe aortic stenosis transcatheter aortic valve implantation (TAVI) has become a feasible therapeutic option. Therefore, the aim of this study was to evaluate the procedural outcomes and mid-term follow-up in this patient group and compare this to octogenarians. METHODS: From 1359 patients who underwent TAVI at our institution between March 2009 and February 2016, 82 patients were nonagenarians and 912 were octogenarians. In nonagenarians, mean age was 91.9±1.4years and compared to octogenarians showed a significantly higher logistic EuroScore (27.7±14.8% vs. 23.1±14.4, p=0.005) and STS Score (8.5±4.8% vs. 6.3±6.7, p=0.001). RESULTS: There were no significant differences with regard to stroke rate, pacemaker implantation rate and major vascular complications between the two groups. Thirty-day mortality was 9.8% in nonagenarians and 4.1% in octogenarians (p=0.04). At 1 year, all-cause mortality increased to 30.9% vs. 18.6% (n.s.). CONCLUSION: Nonagenarians showed an increased periprocedural mortality during TAVI and higher mortality in follow-up compared to octogenarians. Age alone is not a predictive factor but indication for treatment should be carefully evaluated by the heart team on an individual basis.

First Explantation of Direct Flow Medical Transcatheter Valve.

Next-generation transcatheter heart valves are designed to overcome procedure-related adverse events such as vascular complications and annulus rupture, and to minimize paravalvular regurgitation. The Direct Flow Medical valve is fully repositionable and shows promising results. The case is presented of Direct Flow Medical valve implantation in a patient with a functional bicuspid aortic valve. Multiple repositioning maneuvers failed to overcome the anatomic difficulties, and this resulted in a moderately high persisting gradient and moderate paravalvular leakage. Surgical valve explantation was necessary which, to the present authors' knowledge, is the first such case of Direct Flow Medical valve explantation to be performed.

A differentiated morphological parameter-coding system to describe the suitability of mitral valve stenoses intended for percutaneous valvotomy.

Percutaneous balloon-mitral-valvotomy (PBMV) is an alternative to surgery in selected patients with mitral valve (MV) stenosis (MS). Applying echocardiography, suitability for PBMV is assessed by detailed morphological description. Echo-scores alone are suboptimal to describe MV morphology, because single parameters, important for a decision concerning PBMV, are not distinguishable out of a score number. The aim was to design a tool (coding-system), which combines a number for a stenotic MV like scores (for statistical options) and decodable, generally applied parameters describing the MS morphology. The reproducibility of the MS morphology using the coding-system has to be tested in 90 patients. A separate group of 297 patients (pts) with MS, scheduled for PBMV, should be investigated prospectively applying the coding-system and a comparable score. We chose the Wilkins score (WS) as representative of scores. The coding-system is designed as a parameter sequencing set consisting of 6 digits. The first digit indicates a decision code concerning suitability for PBMV. The following 5 digits indicate generally accepted morphological parameters, which are partially also used in the WS. Therefore, the MS morphology can be "read" retrospectively by decoding. 201/297 patients were found suitable for PBMV. Applying the coding-system all 201 suitable patients were correctly distinguished from 96 morphologically unsuitable patients. Astonishingly 48/96 of the rejected patients showed a WS ≤8 whereas 28/201 of the suitable patients demonstrated a WS >8. 25/28 of them showed a successful initial outcome. Applying the generally known threshold of "8" when predicting suitability of a MS, the WS demonstrated an initial success rate of 62 %, sensitivity of 0.87, specificity of 0.45, precision of 0.79, and accuracy of 0.78. Applying the coding-system, the initial success rate was 70.8 %, sensitivity = 0.96, specificity = 1.0, precision = 1.0, and accuracy = 0.97. The coding-system is an advanced diagnostic aid, is statistically applicable, offers a decodable morphological description, includes a decision code regarding suitability for PBMV, and can be used for comparing different groups of patients with MS by calculating "mean morphologies" of groups.

Impact of Access Site on Periprocedural Bleeding and Cerebral and Coronary Events in High-Bleeding-Risk Percutaneous Coronary Intervention: Findings from the RIVA-PCI Trial.

INTRODUCTION: The preference for using transradial access (TRA) over transfemoral access (TFA) in patients requiring percutaneous coronary intervention (PCI) is based on evidence suggesting that TRA is associated with less bleeding and fewer vascular complications, shorter hospital stays, improved quality of life, and a potential beneficial effect on mortality. We have limited study data comparing the two access routes in a patient population with atrial fibrillation (AF) undergoing PCI, who have a particular increased risk of bleeding, while AF itself is associated with an increased risk of thromboembolism. METHODS: Using data from the RIVA-PCI registry, which includes patients with AF undergoing PCI, we analyzed a high-bleeding-risk (HBR) cohort. These patients were predominantly on oral anticoagulants (OAC) for AF, and the PCI was performed via radial or femoral access. Endpoints examined were in-hospital bleeding (BARC 2-5), cerebral events (TIA, hemorrhagic or ischemic stroke) and coronary events (stent thrombosis and myocardial infarction). RESULTS: Out of 1636 patients, 854 (52.2%) underwent TFA, while 782 (47.8%) underwent the procedure via TRA, including nine patients with brachial artery puncture. The mean age was 75.5 years. Groups were similar in terms of age, sex distribution, AF type, cardiovascular history, risk factors, and comorbidities, except for a higher incidence of previous bypass surgeries, heart failure, hyperlipidemia, and chronic kidney disease (CKD) with a glomerular filtration rate (GFR) < 60 ml/min in the TFA group. No clinically relevant differences in antithrombotic therapy and combinations were present at the time of PCI. However, upon discharge, transradial PCI patients had a higher rate of triple therapy, while dual therapy was preferred after transfemoral procedures. Radial access was more frequently chosen for non-ST-segment elevation myocardial infarction (NSTEMI) and unstable angina pectoris (UAP) cases (NSTEMI 26.6% vs. 17.0%, p < 0.0001; UAP 21.5% vs. 14.5%, p < 0.001), while femoral access was more common for elective PCI (60.3% vs. 44.1%, p < 0.0001). No differences were observed for ST-segment elevation myocardial infarction (STEMI). Both groups had similar rates of cerebral events (TFA 0.2% vs. TRA 0.3%, p = 0.93), but the TFA group had a higher incidence of bleeding (BARC 2-5) (4.2% vs. 1.5%, p < 0.01), mainly driven by BARC 3 bleeding (1.5% vs. 0.4%, p < 0.05). No significant differences were found for stent thrombosis and myocardial infarction (TFA 0.2% vs. TRA 0.3%, p = 0.93; TFA 0.4% vs. TRA 0.1%, p = 0.36). CONCLUSIONS: In HBR patients with AF undergoing PCI for acute or chronic coronary syndrome, the use of TRA might be associated with a decrease in in-hospital bleeding, while not increasing the risk of embolic or ischemic events compared to femoral access. Further studies are required to confirm these preliminary findings.

Balloon expandable sheath for transfemoral aortic valve implantation: a viable option for patients with challenging access.

BACKGROUND AND OBJECTIVES: Transcatheter aortic valve replacement (TAVR) via femoral access is a new option for patients with severe aortic valve stenosis considered to be at high risk for conventional open-heart surgery. This procedure requires peripheral arteries that are able to accommodate the large sheaths required for valve delivery. We present a series of patients with suboptimal vascular conditions, who received a self-expandable vascular sheath. METHODS AND RESULTS: From January 2009 to September 2011, a total of 96 patients (43% male) were treated with the 18F Medtronic CoreValve (Medtronic, Minneapolis, MN, USA). The patients' average age was 82.5 ± 4.6 years, and the mean EuroSCORE was 29%. In eight cases, vascular conditions were inadequate either due to advanced atherosclerotic disease (n = 5, 62.5%), or an arterial diameter ≤7 mm (n = 3, 37.5%). Instead of the standard 18F sheath, a balloon-expandable transfemoral introducer (SoloPath Introducer, Onset Medical Corporation, Irvine, CA, USA) was delivered and removed without complications in all but one (87.5%) patient. In the last case, rupture of the right femoral artery occurred after removal of the sheath with the need of vascular surgery. CONCLUSION: The SoloPath sheath is a feasible alternative to conventional sheaths for transfemoral TAVR patients with difficult femoral vascular access.

Delayed coronary ischemia after transfemoral aortic valve implantation.

Transcatheter aortic valve implantation (TAVI) offers a less invasive treatment alternative to surgical aortic valve replacement for high-risk patients. Although the procedure can be performed at low risk, life-threatening complications may arise in single cases during or even months after the procedure. Here, the details are presented of two patients who underwent TAVI by a transfemoral approach with Medtronic CoreValve prostheses and suffered myocardial ischemia months later. The patients' anatomy with small aortic root, narrow sinus of Valsalva and small distance between the annulus base and coronary arteries and/or the relative oversizing of the CoreValve prosthesis with a high positioning may have contributed to this late complication. Hence, caution is mandatory in this type of patient, with exact pre-procedural planning and close follow up required.

Rivaroxaban in Patients With Atrial Fibrillation Who Underwent Percutaneous Coronary Intervention in Clinical Practice.

Little is known about the efficacy and safety of rivaroxaban in patients with atrial fibrillation (AF) who underwent percutaneous coronary intervention (PCI) in clinical practice. We therefore conducted a prospective observational study to determine the rate of ischemic, embolic, and bleeding events in patients with AF and PCI treated with rivaroxaban in a real-world experience. The RIVA-PCI ("rivaroxaban in patients with AF who underwent PCI") (clinicaltrials.gov NCT03315650) is a prospective, noninterventional, multicenter study with a follow-up until 14 months, including patients with AF who underwent PCI discharged with rivaroxaban. Between January 2018 and March 2020, 700 patients with PCI treated with rivaroxaban (elective in 50.1%, non-ST-elevation acute coronary syndrome 43.0%, ST-elevation myocardial infarction in 6.9%) were enrolled at 51 German hospitals. After PCI, a dual antithrombotic therapy consisting of rivaroxaban and a P2Y12 inhibitor was administered in 70.7% and triple antithrombotic therapy in 27.9%, respectively. Follow-up information could be obtained in 695 patients (99.3%). Rivaroxaban has been stopped prematurely in 21.6% of patients. Clinical events under rivaroxaban during the 14-month follow-up compared with those observed in the PIONEER-AF PCI trial included cardiovascular death (2.0% % vs 2.0%), myocardial infarction (0.9% vs 3.0%), stent thrombosis (0.2% vs 0.8%), stroke (1.3% vs 1.3%), International Society on Thrombosis and Haemostasis major (4.2% vs 3.9%), and International Society on Thrombosis and Haemostasis nonmajor clinically relevant bleeding (15.3% vs 12.9%). Therefore, in this real-world experience, rivaroxaban in patients with AF who underwent PCI is associated with ischemic and bleeding event rates comparable with those observed in the randomized PIONEER-AF PCI trial.

Hemodynamic Performance of Two Current-Generation Transcatheter Heart Valve Prostheses in Severely Calcified Aortic Valve Stenosis.

BACKGROUND: Treatment of severely calcified aortic valve stenosis is associated with a higher rate of paravalvular leakage (PVL) and permanent pacemaker implantation (PPI). We hypothesized that the self-expanding transcatheter heart valve (THV) prostheses Evolut Pro (EPro) is comparable to the balloon-expandable Sapien 3 (S3) regarding hemodynamics, PPI, and clinical outcome in these patients. METHODS: From 2014 to 2019, all patients with very severe calcification of the aortic valve who received an EPro or an S3 THV were included. Propensity score matching was utilized to create two groups of 170 patients. RESULTS: At discharge, there was significant difference in transvalvular gradients (EPro vs. S3) (dPmean 8.1 vs. 11.1 mmHg, p ≤ 0.001) and indexed effective orifice area (EOAi) (1.1 vs. 0.9, p ≤ 0.001), as well as predicted EOAi (1 vs. 0.9, p ≤ 0.001). Moderate patient prosthesis mismatch (PPM) was significantly lower in the EPro group (17.7% vs. 38%, p ≤ 0.001), as well as severe PPM (2.9% vs. 8.8%, p = 0.03). PPI and the PVL rate as well as stroke, bleeding, vascular complication, and 30-day mortality were comparable. CONCLUSIONS: In patients with severely calcified aortic valves, both THVs performed similarly in terms of 30-day mortality, PPI rate, and PVL occurrence. However, patient prothesis mismatch was observed more often in the S3 group, which might be due to the intra-annular design.

Real-time three-dimensional transoesophageal echocardiography during percutaneous transcatheter occlusion of mitral periprosthetic paravalvular leak.

We present the case of an 86-year-old female patient with a history of mitral valve replacement due to relevant stenosis. After surgery, an increasing periprosthetic valvular leak (PVL) became obvious causing regurgitation and an increasing haemolysis. Conventional two-dimensional transoesophageal echocardiography (2D TEE) showed a defect of 15 mm length located from the lateral to the posterior circumference subdivided by two surgical sutures into three parts. The patient refused additional surgical therapy. Hence, we suggested a percutaneous transcatheter occlusion of the leakage with a 12 × 5 mm Amplatzer(®) Vascular Plug III device (AVP) (AGA Medical Corporation, Plymouth, MA, USA). The placement of the device was supported indispensably by real-time three-dimensional TEE. The device occluded the leakage nearly completely and downgraded the regurgitation from moderate to neglectable. Also haemolytic parameters improved significantly. V-wave decreased promptly from 70 to 35 mmHg after placing AVP. Percutaneous closure of PVL by AVP, a self-expandable nitinol device approved for peripheral vessel occlusion, is described in limited cases with more or less successful results. It is graded as a technically demanding procedure reserved to poor surgical candidates. The main challenge is finding and intubating the leakage and the correct placement of the device. Three-dimensional TEE seems to be superior to conventional 2D TEE as it allows an easier guidance of the device into the defect. Hence, it is strongly recommended for this intracardiac intervention.

Idiopathic pulmonary arterial hypertension phenotypes determined by cluster analysis from the COMPERA registry.

The term idiopathic pulmonary arterial hypertension (IPAH) is used to categorize patients with pre-capillary pulmonary hypertension of unknown origin. There is considerable variability in the clinical presentation of these patients. Using data from the Comparative, Prospective Registry of Newly Initiated Therapies for Pulmonary Hypertension, we performed a cluster analysis of 841 patients with IPAH based on age, sex, diffusion capacity of the lung for carbon monoxide (DLCO; <45% vs ≥45% predicted), smoking status, and presence of comorbidities (obesity, hypertension, coronary heart disease, and diabetes mellitus). A hierarchical agglomerative clustering algorithm was performed using Ward's minimum variance method. The clusters were analyzed in terms of baseline characteristics; survival; and response to pulmonary arterial hypertension (PAH) therapy, expressed as changes from baseline to follow-up in functional class, 6-minute walking distance, cardiac biomarkers, and risk. Three clusters were identified: Cluster 1 (n = 106; 12.6%): median age 45 years, 76% females, no comorbidities, mostly never smokers, DLCO ≥45%; Cluster 2 (n = 301; 35.8%): median age 75 years, 98% females, frequent comorbidities, no smoking history, DLCO mostly ≥45%; and Cluster 3 (n = 434; 51.6%): median age 72 years, 72% males, frequent comorbidities, history of smoking, and low DLCO. Patients in Cluster 1 had a better response to PAH treatment than patients in the 2 other clusters. Survival over 5 years was 84.6% in Cluster 1, 59.2% in Cluster 2, and 42.2% in Cluster 3 (unadjusted p < 0.001 for comparison between all groups). The population of patients diagnosed with IPAH is heterogenous. This cluster analysis identified distinct phenotypes, which differed in clinical presentation, response to therapy, and survival.

Two-dimensional strain and strain rate imaging of the right ventricle in adult patients before and after percutaneous closure of atrial septal defects.

AIMS: Echocardiographic speckle tracking or two-dimensional (2D) strain analysis is a new tool to assess myocardial function. This prospective controlled study evaluates systolic right ventricular (RV) function by 2D strain in adult patients with atrial septal defect (ASD) before and 3 months after percutaneous closure. METHODS AND RESULTS: Assessment of global longitudinal strain (GLS), global longitudinal strain rate (GLSR), and regional peak systolic strain (PSS) of right ventricle was performed in 33 ASD patients. The data were compared with those from 34 age-matched adults with patent foramen ovale. Before percutaneous closure, mean GLS was significantly increased in comparison to control group, and significantly reduced after closure. Analysis of regional PSS showed significant decrease in the lateral apical, lateral mid, and septal apical segments. GLSR was not influenced by ASD closure. CONCLUSION: Two-dimensional strain appears to be helpful also for the assessment of RV function and its response to correction of volume overload.

Transcatheter Aortic Valve Implantation in Patients With Pre-Existing Mechanical Mitral Valve Prostheses.

OBJECTIVES: Transcatheter aortic valve implantation (TAVI) has become standard therapy for aortic stenosis patients with intermediate or high operative risk. Treatment of patients with pre-existing mechanical mitral valve replacement (MVR) is challenging due to possible interference between the TAVI prosthesis and MVR. We present our single-center experience with this special patient cohort. METHODS: A total of 1960 patients underwent TAVI at our institution between 2009 and March 2018; of these, 16 patients had pre-existing mechanical MVR. Device success and adverse events were analyzed according to the Valve Academic Research Consortium (VARC)-2 criteria. Patients were followed for at least 12 months. RESULTS: Mean patient age was 81.5 ± 4.4 years. The patients had a mean logistic EuroScore of 37.1 ± 13.5% and STS score of 7.1 ± 3.2%. Successful valve deployment was achieved in all patients, peri-interventional stroke rate was 0.0%, and permanent pacemaker was implanted in 2 patients (12.5%). Two patients experienced major complications, with blockage of the MVR disc in 1 patient and annulus rupture in 1 patient. Hence, 30-day mortality was 12.5% and 1-year mortality was 25.0%. CONCLUSION: TAVI in patients with mechanical MVR is challenging and requires careful preparation and choice of TAVI device. Repositionable and retrievable devices seem to be a safer option.

Feasibility of Transfemoral Aortic Valve Implantation in Patients With Aortic Disease and Simultaneous or Sequential Endovascular Aortic Repair.

OBJECTIVES: The transfemoral approach for transcatheter aortic valve implantation (TF-TAVI) is associated with a significant survival benefit for intermediate and high-risk patients. Due to the increased procedural risk, many operators avoid TF-TAVI in patients with aortic disease. Moreover, significant peri-interventional device interaction may occur in patients with previous endovascular aortic repair (EVAR). We evaluated the feasibility of TF-TAVI in patients with aortic disease in combination with simultaneous or sequential EVAR. METHODS: Data from 15 TF-TAVI patients with concomitant aortic disease treated between 2009 and 2019 in three German heart centers representing 4410 TAVI procedures were analyzed. RESULTS: Two patients with progressive penetrating atherosclerotic ulcers (PAUs) in the descending thoracic aorta underwent sequential and simultaneous thoracic EVAR (TEVAR), respectively. One patient with stable PAU and 4 patients with not yet relevant abdominal aortic aneurysm (AAA) underwent isolated TF-TAVI. One patient with relevant AAA underwent TF-TAVI and sequential EVAR. Seven patients with previous EVAR due to an AAA underwent TF-TAVI (5 with a bifurcated graft and 2 with a straight graft). TF-TAVI and sequential or simultaneous TEVAR were technically successful in all patients. Vascular complications occurred in 1 patient. One patient died within 30 days and 2 patients died within 12 months. CONCLUSION: TF-TAVI can be performed successfully in patients with aortic disease or previous endovascular aortoiliac intervention. Simultaneous and sequential (T)EVAR is feasible.

Severe calcification of the lateral mitral annulus in constrictive pericarditis: a potential pitfall for the use of echocardiographic tissue Doppler imaging.

According to the guidelines of the European Society of Cardiology on the diagnosis and management of pericardial diseases, tissue Doppler imaging (TDI) is proposed to be part of the diagnostic work-up in patients with suspected constrictive pericarditis (CP). We describe a case which illustrates that TDI analysis may be misleading in patients with severe pericardial calcifications of the lateral mitral annulus. Multi-slice computed tomography (MSCT) data in this case contributed much to a better understanding of the impact of heterogeneous calcification patterns on the results of TDI assessment in CP.