Sex-related characteristics and short-term outcomes of patients undergoing transcatheter tricuspid valve intervention for tricuspid regurgitation.

AIMS: The impact of sexuality in patients with significant tricuspid regurgitation (TR) undergoing transcatheter tricuspid valve intervention (TTVI) is unknown. The aim of this study was to investigate sex-specific outcomes in patients with significant TR treated with TTVI vs. medical therapy alone. METHODS AND RESULTS: The Transcatheter Tricuspid Valve Therapies (TriValve) registry collected data on patients with significant TR from 24 centres who underwent TTVI from 2016 to 2021. A control cohort was formed by medically managed patients with ≥severe isolated TR diagnosed in 2015-18. The primary endpoint was freedom from all-cause mortality. Secondary endpoints were heart failure (HF) hospitalization, New York Heart Association (NYHA) functional status, and TR severity. One-year outcomes were assessed for the TriValve cohort and compared with the control cohort with the inverse probability of treatment weighting (IPTW). A total of 556 and 2072 patients were included from the TriValve and control groups, respectively. After TTVI, there was no difference between women and men in 1-year freedom from all-cause mortality 80.9% vs. 77.9%, P = 0.56, nor in HF hospitalization (P = 0.36), NYHA Functional Classes III and IV (P = 0.17), and TR severity >2+ at last follow-up (P = 0.42). Multivariable Cox-regression weighted by IPTW showed improved 1-year survival after TTVI compared with medical therapy alone in both women (adjusted hazard ratio 0.45, 95% confidence interval 0.23-0.83, P = 0.01) and men (adjusted hazard ratio 0.42, 95% confidence interval 0.18-0.89, P = 0.03). CONCLUSION: After TTVI in high-risk patients, there were no sex-related differences in terms of survival, HF hospitalization, functional status, and TR reduction up to 1 year. The IPTW analysis shows a survival benefit of TTVI over medical therapy alone in both women and men.

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.

Comparison of Self-Expanding RDV Perceval S versus TAVI ACURATE neo/TF.

BACKGROUND: Rapid deployment aortic valve replacement (RDAVR) and transcatheter aortic valve implantation (TAVI) have emerged as increasingly used alternatives to conventional aortic valve replacement to treat patients at higher surgical risk. Therefore, in this single-center study, we retrospectively compared clinical outcomes and hemodynamic performance of two self-expanding biological prostheses, the sutureless and rapid deployment valve (RDV) Perceval-S (PER) and the transcatheter heart valve (THV) ACURATE neo/TF (NEO) in a 1:1 propensity-score-matching (PSM) patient cohort. METHODS: A total of 332 consecutive patients with symptomatic aortic valve stenosis underwent either singular RDAVR with PER (119) or TAVI with NEO (213) at our institutions between 2012 and 2017. To compare the unequal patient groups, a 1:1 PSM for preoperative data and comorbidities was conducted. Afterward, 59 patient pairs were compared with regard to relevant hemodynamic parameter, relevant paravalvular leak (PVL), permanent postoperative pacemaker (PPM) implantation rate, and clinical postoperative outcomes. RESULTS: Postoperative clinical short-term outcomes presented with slightly higher rates for 30-day all-cause mortality (PER = 5.1% vs. NEO = 1.7%, p = 0.619) and major adverse cardiocerebral event in PER due to cerebrovascular events (transient ischemic attack [TIA]-PER = 3.4% vs. TIA-NEO = 1.7%, p = 0.496 and Stroke-PER = 1.7% vs. Stroke-NEO = 0.0%, p = 1). Moreover, we show comparable PPM rates (PER = 10.2% vs. NEO = 8.5%, p = 0.752). However, higher numbers of PVL (mild-PER = 0.0% vs. NEO = 55.9%, p = 0.001; moderate or higher-PER = 0.0% vs. NEO = 6.8%, p = 0.119) after TAVI with NEO were observed. CONCLUSION: Both self-expanding bioprostheses, the RDV-PER and THV-NEO provide a feasible option in elderly and patients with elevated perioperative risk. However, the discussed PER collective showed more postoperative short-term complications with regard to 30-day all-cause mortality and cerebrovascular events, whereas the NEO showed higher rates of PVL.

Current Status of Catheter-based Mitral Valve Replacement.

PURPOSE OF REVIEW: Transcatheter mitral valve replacement (TMVR) has been developed to address the need for an alternative therapeutic option to surgery in patients suffering from severe mitral regurgitation who are at high surgical risk. The present review illustrated the state-of-the-art of catheter-based mitral valve replacement evaluating technical characteristics and early clinical experience of different devices to outline prospects and challenges of TMVR. RECENT FINDINGS: Several devices are currently under clinical assessment. Early experience has demonstrated high procedural success of TMVR. However, TMVR faces several possible hurdles such as left ventricular outflow tract obstruction (LVOTO) after prosthesis deployment, access site complications, and thrombotic risk requiring anticoagulatory therapy. Future studies should assess long-term prosthesis stability, optimal anticoagulation regime, and occurrence of paravalvular leakage. The development of smaller TMVR prostheses suitable for transseptal implantation could overcome bleeding complications. In perspective, TMVR may emerge to a clinically relevant therapeutic approach for patients with severe MR at high surgical risk.

Long-term outcomes after transcatheter aortic valve implantation in failed bioprosthetic valves.

AIMS: Due to bioprosthetic valve degeneration, aortic valve-in-valve (ViV) procedures are increasingly performed. There are no data on long-term outcomes after aortic ViV. Our aim was to perform a large-scale assessment of long-term survival and reintervention after aortic ViV. METHODS AND RESULTS: A total of 1006 aortic ViV procedures performed more than 5 years ago [mean age 77.7 ± 9.7 years; 58.8% male; median STS-PROM score 7.3% (4.2-12.0)] were included in the analysis. Patients were treated with Medtronic self-expandable valves (CoreValve/Evolut, Medtronic Inc., Minneapolis, MN, USA) (n = 523, 52.0%), Edwards balloon-expandable valves (EBEV, SAPIEN/SAPIEN XT/SAPIEN 3, Edwards Lifesciences, Irvine, CA, USA) (n = 435, 43.2%), and other devices (n = 48, 4.8%). Survival was lower at 8 years in patients with small-failed bioprostheses [internal diameter (ID) ≤ 20 mm] compared with those with large-failed bioprostheses (ID > 20 mm) (33.2% vs. 40.5%, P = 0.01). Independent correlates for mortality included smaller-failed bioprosthetic valves [hazard ratio (HR) 1.07 (95% confidence interval (CI) 1.02-1.13)], age [HR 1.21 (95% CI 1.01-1.45)], and non-transfemoral access [HR 1.43 (95% CI 1.11-1.84)]. There were 40 reinterventions after ViV. Independent correlates for all-cause reintervention included pre-existing severe prosthesis-patient mismatch [subhazard ratio (SHR) 4.34 (95% CI 1.31-14.39)], device malposition [SHR 3.75 (95% CI 1.36-10.35)], EBEV [SHR 3.34 (95% CI 1.26-8.85)], and age [SHR 0.59 (95% CI 0.44-0.78)]. CONCLUSIONS: The size of the original failed valve may influence long-term mortality, and the type of the transcatheter valve may influence the need for reintervention after aortic ViV.

Feasibility and rationale of direct current cardioversion immediately after transcatheter percutaneous edge-to-edge mitral valve repair.

AIMS: Atrial fibrillation (AF) is a frequent comorbidity among patients with severe mitral regurgitation (MR). Direct current (DC) cardioversion is one of the strategies for rhythm control. However, the safety and feasibility of immediate DC cardioversion after MitraClip are not elucidated. METHODS AND RESULTS: In this study, patients with symptomatic severe MR who underwent MitraClip were included. After fixing the MR, synchronized DC cardioversion was attempted for those with AF. A total of consecutive 60 patients, 36 subjects (60%), comorbid with AF. DC cardioversion was performed in 30 patients (mean age of 76.0 ± 9.3 years), and the successful conversion was achieved in 15 patients (50%). There was no any adverse event related to the cardioversion. Subjects with sustained conversion to SR experienced significant improvement in 6MWT (failed: 285 ± 110-308 ± 135 m, P = .278; successful: 269 ± 109 m-328 ± 78, P = .047) and reduction in NT-proBNP level (failed: 4411 ± 7401-3296 ± 4299 ng/mL, P = .217; successful: 4094 ± 2735-2353 ± 2856 ng/mL, P = .026) at 1 month. CONCLUSIONS: Direct current cardioversion seemed to be safe and feasible immediately after the transcatheter edge-to-edge mitral valve repairs. Subjects who maintain SR experienced better functional improvement.

Correlation between Doppler echocardiography and right heart catheterization assessment of systolic pulmonary artery pressure in patients with severe aortic stenosis.

OBJECTIVES: The aim of this study was to investigate reliability and accuracy of noninvasive measurement method by echocardiography compared to invasive measurement of systolic pulmonary artery pressure (SPAP) in a large cohort of aortic stenosis (AS) patients. BACKGROUND: Pulmonary hypertension (PH) is common in patients with cardiac disease, especially in left heart disease like severe AS. Invasive measurement by right heart catheterization (RHC) is the gold standard to assess pulmonary pressures. Nevertheless, echocardiography is widely used in everyday practice for estimation of pulmonary pressures and diagnosing PH. METHODS: A total of 1400 patients with AS and full invasive hemodynamic assessment by RHC and noninvasive measurements by Doppler echocardiography were included. RESULTS: Mean patient age was 81.5 ± 6.8 years, and 46.3% were males. SPAP was 44.7 ± 15.1 mm Hg by echocardiography and 45.3 ± 15.2 mm Hg by RHC. Pearson's correlation coefficient was r = .820 (P < .0001). Bland-Altman analysis showed a bias of -0.56 mm Hg (95% limits of agreement -18.38 to + 17.26 mm Hg) and 80.6% measurement accuracy. Pulmonary hypertension defined by RHC as a mean PAP ≥25 mm Hg was reliably diagnosed via an echocardiographically measured SPAP of >40 mm Hg (82.2% sensitivity, 80.2% specificity, 83.1% positive predictive value, 79.2% negative predictive value). CONCLUSIONS: In a large cohort of patients with severe aortic stenosis, we could demonstrate a very good correlation of SPAP between Doppler echocardiography and invasive RHC measurement. Pulmonary hypertension could be diagnosed by echocardiography with high sensitivity and specificity.

Patients at low surgical risk as defined by the Society of Thoracic Surgeons Score undergoing isolated interventional or surgical aortic valve implantation: in-hospital data and 1-year results from the German Aortic Valve Registry (GARY).

AIMS: Transcatheter aortic valve implantation (TAVI) has become the standard treatment for patients with severe aortic valve stenosis at high surgical risk and may be considered for patients with intermediate risk. During the last few years, an increasing number of patients with low surgical risk have been treated with TAVI. In this study, low-risk patients undergoing isolated TAVI or surgical aortic valve replacement (SAVR) were analysed using data from the German Aortic Valve Registry (GARY). METHODS AND RESULTS: All patients with a Society of Thoracic Surgeons Score of <4% undergoing TAVI or SAVR in 2014 and 2015 were evaluated. A total of 20 549 low surgical risk patients remained for further analysis, comprising 14 487 surgical patients and 6062 TAVI patients. Since TAVI patients were significantly older and had significantly more co-morbidities, a weighted propensity score model was used to compare SAVR and TAVI patients for in-hospital, 30-day, and 1-year mortality. Transcatheter aortic valve implantation patients showed a significantly higher in-hospital and 30-day survival than SAVR patients (in hospital survival TAVI vs. SAVR: 98.5% vs. 97.3%; P = 0.003; 30-day survival TAVI vs. SAVR: 98.1% vs. 97.1%; P = 0.014). At 1 year, survival rates did not differ significantly (survival TAVI vs. SAVR: 90.0% vs. 91.2%; P = 0.158). CONCLUSION: In this first GARY analysis of low-risk patients, weighted comparison showed similar 1-year survival for TAVI and SAVR and higher in-hospital survival for TAVI patients.

Incidence and outcome of peri-procedural transcatheter heart valve embolization and migration: the TRAVEL registry (TranscatheteR HeArt Valve EmboLization and Migration).

AIMS: Peri-procedural transcatheter valve embolization and migration (TVEM) is a rare but potentially devastating complication of transcatheter aortic valve implantation (TAVI). We sought to assess the incidence, causes, and outcome of TVEM in a large multicentre cohort. METHODS AND RESULTS: We recorded cases of peri-procedural TVEM in patients undergoing TAVI between January 2010 and December 2017 from 26 international sites. Peri-procedural TVEM occurred in 273/29 636 (0.92%) TAVI cases (age 80.8 ± 7.3 years; 53.8% female), of which 217 were to the ascending aorta and 56 to the left ventricle. The use of self-expanding or first-generation prostheses and presence of a bicuspid aortic valve were independent predictors of TVEM. Bail-out measures included repositioning attempts using snares or miscellaneous tools (41.0%), multiple valve implantations (83.2%), and conversion to surgery (19.0%). Using 1:4-propensity matching, we identified a cohort of 235 patients with TVEM (TVEMPS) and 932 patients without TVEM (non-TVEMPS). In the matched cohort, all-cause mortality was higher in TVEMPS than in non-TVEMPS at 30 days (18.6% vs. 4.9%; P < 0.001) and after 1 year (30.5% vs. 16.6%; P < 0.001). Major stroke was more frequent in TVEMPS at 30 days (10.6% vs. 2.8%; P < 0.001), but not at 1 year (4.6% vs. 1.9%; P = 0.17). The need for emergent cardiopulmonary support, major stroke at 30 days, and acute kidney injury Stages 2 and 3 increased the risk of 1-year mortality, whereas a better renal function at baseline was protective. CONCLUSION: Transcatheter valve embolization and migration occurred in approximately 1% and was associated with increased morbidity and mortality.

Patients at Intermediate Surgical Risk Undergoing Isolated Interventional or Surgical Aortic Valve Implantation for Severe Symptomatic Aortic Valve Stenosis.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is increasingly being used for treatment of severe aortic valve stenosis in patients at intermediate risk for surgical aortic valve replacement (SAVR). Currently, real-world data comparing indications and clinical outcomes of patients at intermediate surgical risk undergoing isolated TAVR with those undergoing SAVR are scarce. METHODS: We compared clinical characteristics and outcomes of patients with intermediate surgical risk (Society of Thoracic Surgeons score 4%-8%) who underwent isolated TAVR or conventional SAVR within the prospective, all-comers German Aortic Valve Registry. RESULTS: A total of 7613 patients at intermediate surgical risk underwent isolated TAVR (n=6469) or SAVR (n=1144) at 92 sites in Germany between 2012 and 2014. Patients treated by TAVR were significantly older (82.5±5.0 versus 76.6±6.7 years, P<0.001) and had higher risk scores (logistic EuroSCORE [European System for Cardiac Operative Risk Evaluation]: 21.2±12.3% versus 14.2±9.5%, P<0.001; Society of Thoracic Surgeons score: 5.6±1.1 versus 5.2±1.0, P<0.001). Multivariable analyses revealed that advanced age, coronary artery disease, New York Heart Association class III/IV, pulmonary hypertension, prior cardiac decompensation, elective procedure, arterial occlusive disease, no diabetes mellitus, and a smaller aortic valve area were associated with performing TAVR instead of SAVR (all P<0.001). Unadjusted in-hospital mortality rates were equal for TAVR and SAVR (3.6% versus 3.6%, P=0.976), whereas unadjusted 1-year mortality was significantly higher in patients after TAVR (17.5% versus 10.8%, P<0.001). After propensity score matching, the difference in 1-year mortality between patients with TAVR and SAVR was no longer significant (17.1% versus 15.7%, P=0.59). CONCLUSIONS: Patients at intermediate risk undergoing TAVR differ significantly from those treated with SAVR with regard to age and baseline characteristics. Isolated TAVR and SAVR were associated with an in-hospital mortality rate of 3.6%. In the propensity score analysis, there was no significant difference in 1-year mortality between patients with TAVR and SAVR.

The clip and the tip: Lessons learned from ablation of atrial fibrillation in patients postpercutaneous mitral valve repair.

BACKGROUND: Atrial fibrillation (AF) and higher grade mitral valve regurgitation are often associated. For both, there are interventional therapeutic options such as pulmonary vein isolation (PVI) and percutaneous mitral valve repair (PMVR) using MitraClip. OBJECTIVE: This study investigated the feasibility, safety and clinical outcome of AF ablation in patients with prior PMVR. METHODS: This study included patients with symptomatic AF who underwent PVI after prior PMVR at a tertiary care center (14 consecutive patients, group I). A propensity-score matched group of 42 patients (1:3 matching, group II) without prior valve repair acted as controls. RESULTS: Acute PVI was achieved in all patients. No difference was found regarding median procedure time (group I: 125.0 [Q1: 120.0; Q3: 176.3] vs group II: 135.0 [120.0; 177.5] minutes; P = 0.87) and median fluoroscopy duration (group I: 17.2 [12.9; 25.9] vs group II: 18.6 [12.3; 25.9] minutes; P = 0.95). In group I, one patient suffered a postprocedural transient ischemic attack. No further major complications occurred (P = 0.25). No periprocedural interference with the MitraClip was noted. The Kaplan-Meier estimate 18-month overall arrhythmia-free survival after the index procedure including a 3-month blanking period was 64.8% (95% confidence interval [CI] 42.1-99.8%) for the study group and 68.3% (95% CI, 54.6-85.6%) for the control group P = 0.35). A higher percentage of left atrial tachycardias was observed in the study group (67% vs 12% of patients with any arrhythmia recurrence; P = 0.01). CONCLUSION: Catheter ablation of AF in patients with prior PMVR is feasible and safe and results in satisfying clinical outcome.

Impact of prosthesis-iteration evolution and sizing practice on the incidence of prosthesis-patient mismatch after transcatheter aortic valve replacement.

OBJECTIVES: To investigate the impact of the introduction of the next generation self-expanding (SE) and balloon-expandable (BE) transcatheter heart valves (THVs) on the incidence of prosthesis-patient mismatch (PPM) after transcatheter aortic valve replacement (TAVR). BACKGROUND: PPM is a risk factor for accelerated degeneration of bioprosthetic aortic valves. Data on PPM after TAVR are derived mainly from studies of older generation THVs. METHODS: PPM was assessed at 30 days post-TAVR with the older generation (Medtronic CoreValve, n = 120 and Edwards Sapien XT, n = 121) and the next generation THVs (Medtronic Evolut R/Pro, n = 136 and Edwards Sapien 3, n = 363). RESULTS: The incidence of any and severe PPM was 15.1% and 0.0% for the older generation THVs, and 42.8% and 12.1% for the next generation THVs. The incidence of moderate and severe PPM was 23.3% and 3.5% in patients who received an Evolut R/Pro vs. 33.1% and 14.7% in those who received a Sapien 3 (P < 0.001). On multivariable analysis, TAVR with the Sapien 3 THV was not associated with PPM, while left ventricular ejection fraction (0.97 [0.95-0.99], P = 0.002), history of myocardial infarction (2.09 [1.00-4.34], P = 0.049), annulus maximum diameter (0.84 [0.77-0.92], P < 0.001), and THV oversizing (0.90 [0.87-0.94], P < 0.001) were independently associated with PPM. In Sapien 3, the risk of any and severe PPM was higher in those with no oversizing (odds ratio: 3.25 [1.23-8.53], P = 0.017 and 5.79[2.33-14.36], P < 0.001). CONCLUSIONS: The incidence of PPM in contemporary TAVR is significant, especially with the next generation BE THV without adequate oversizing.

Treatment Challenges in Patients with Acute Heart Failure and Severe Aortic Valve Stenosis.

PURPOSE OF REVIEW: The goal of this paper is to describe the treatment challenges in patients with aortic stenosis in combination with a reduced left ventricular function. RECENT FINDINGS: Since the risk of mortality is increased in this patient population, transcatheter aortic valve implantation emerged as an important treatment option. Concomitant factors such as mitral regurgitation or coronary artery disease are important co-factors that need to be evaluated and taken into account for treatment decision. Treatment of the severe aortic stenosis is key in this complex setting. Since several co-factors may exist in addition to aortic stenosis, treatment needs to be decided by a Heart Team.

Antegrade-transseptal approach for left ventricular tachyarrhythmia in patients with previous Mitraclip implantation.

Aims: Antegrade-transseptal approach to treat left ventricular tachyarrhythmia (LVT) is useful and widespread. Meanwhile, Mitraclip has been recently introduced as an alternative to mitral valve surgery for severe mitral regurgitation, usually coexisting with ventricular arrhythmias. However, data on the antegrade approach for mapping and ablating LVT in these patients are insufficient. We evaluated the feasibility and clinical impact of the antegrade approach for LVT after Mitraclip implantation. Methods and results: We included five patients (all men; age 72.6 ± 10.5 years) with Mitraclip implantation who underwent catheter ablation for LVT and employed the antegrade approach. Post-ablation mitral valve function was systematically evaluated by transthoracic echocardiography. Six procedures with the antegrade approach were performed on the five patients; three of these patients developed electrical storm. The number of implanted Mitraclip was 1 in two patients, 2 in two patients, and 3 in one patient, for a mean duration of 417 ± 324 days before ablation. After 117-day median follow-up, there was no recurrence of electrical storm, but ventricular tachyarrhythmia recurred and required implantable cardioverter defibrillator therapy in one patient (only sporadic anti-tachycardia pacing); two patients died because of reasons other than ventricular arrhythmia. There was no procedure-related injury on the mitral valve immediately and 3 months after ablation. Conclusions: Antegrade ablation of LVT after Mitraclip implantation may be feasible. Non-arrhythmic death during follow-up suggested the need for comprehensive evaluation before and after ablation.

MitraClip in Patients With Mitral Regurgitation and Left Ventricular Ejection Fraction <30%　- Potential Implications for the Treatment of Patients in Japan.

BACKGROUND: The effect of the unique Japanese indication for MitraClip based on left ventricular ejection fraction (LVEF) is unclear. Methods and Results: We analyzed 874 patients who underwent MitraClip because of mitral regurgitation (MR) and compared the characteristics and outcomes between patients with LVEF <30% and ≥30%. Patients with LVEF ≤30% accounted for 33% of the study population and had a higher prevalence of functional MR. Severity of MR after MitraClip was comparable, and LVEF <30% did not independently affect survival. CONCLUSIONS: Japanese unique indication based on LVEF may exclude one third of patients who were treated with MitraClip in Europe.

Heart Failure Interventions Targeting Impaired Left Ventricles in Structural Heart Disease.

PURPOSE OF REVIEW: Interventional techniques have been developed for a wide spectrum of mechanisms of heart failure (HF), especially in valvular heart disease and cardiomyopathies (ischaemic cardiomyopathy and hypertrophic cardiomyopathy). In this article, we review recent reports on catheter interventions to treat patients with HF. RECENT FINDINGS: Direct modification using the Parachute device and the REVIVENT-TC device for patients with impaired left ventricle with large infarct scars improves geometry and haemodynamic efficiency, resulting in a reduction of HF symptoms. Interatrial shunt therapy improves symptoms and quality of life in HF patients. Uniquely, left ventricular outflow tract obstruction has also been targeted in patients with transcatheter mitral valve implantation. For advanced stage HF patients with prohibitively high surgical risk, emerging transcatheter interventions make it possible to modify life-limiting symptoms. Further results on HF interventions are expected from ongoing clinical trials.

Rationale of cerebral protection devices in left atrial appendage occlusion.

AIMS: Aims of this case-series were to assess the feasibility of cerebral protection devices in interventional left atrial appendage occlusion (iLAAO) procedures and to yield insight into the pathomorphological correlate of early, procedural cerebral embolization during iLAAO. METHODS AND RESULTS: Five consecutive patients underwent iLLO flanked by the Sentinel CPS® (Claret Medical, Inc., Santa Rosa, CA) cerebral protection system. Placement and recapture of the Sentinel® device as well as the iLAAO were successful and safe in all cases. Histomorphometric analysis of the collected filters showed embolized debris in all patients. Acute thrombus was found in three patients, organizing thrombus in four. Interestingly, two patients had endocardial or myocardial tissue in their filters. CONCLUSIONS: Cerebral protection during iLAAO with the Sentinel CPS® device is feasible. Furthermore, this dataset identifies the formation and embolization of thrombus and cardiac tissue as emboligeneic sources and potential future targets to reduce procedural complications. © 2016 Wiley Periodicals, Inc.

"Shock and Go?" extracorporeal cardio-pulmonary resuscitation in the golden-hour of ROSC.

OBJECTIVES: The feasibility and outcomes of 35 consecutive patients subjected to eCPR in the tertiary cardiology center were investigated. BACKGROUND: While conventional cardiopulmonary-resuscitation (cCPR) often times achieves only mediocre outcomes extracorporeal cardiopulmonary-resuscitation (eCPR) increasingly shifts into the focus of interest. However, the scientific evidence for eCPR is sparse, particularly in the cardiological setting. METHODS: Retrospective chart analysis of 35 patients treated with eCPR between 01/2014 and 10/2015. RESULTS: The duration of cCPR until initiation of eCPR was 73.8 ± 37.6 min and resulted in an initial pH of 6.9 ± 0.2 and serum lactate level of 14.5 ± 4.8 mmol/L. About 62% (n = 22) of the patients suffered from out of hospital cardiac arrest (OHCA), 85% (n = 30) of the overall events were witnessed and bystander-CPR performed in 77% (n = 27) of cases. Cause of arrest was dominated by acute myocardial infarction (AMI, 71%), initial rhythm to a lesser degree by ventricular fibrillation/tachycardia (VF/VT, 57%). Almost all patients (n = 33, 94%) experienced return of spontaneous circulation (ROSC) after establishing extracorporeal life support (ECLS). In all 57% patients were successfully weaned from ECLS. Survival to discharge was 31% with predominantly good cerebral performance category (CPC 1-2). Survivors were more likely to receive bystander-CPR (P = 0.03) and the duration of cCPR until initiation of eCPR was significantly shorter (P = 0.004). CONCLUSIONS: Our data proves the exceptional level of efficiency of eCPR particularly when Bystander-CPR has been initiated and there is a short duration of cCPR. © 2016 Wiley Periodicals, Inc.

Clinical impact of paravalvular leaks on biomarkers and survival after transcatheter aortic valve implantation.

BACKGROUND: There is accumulating evidence that up to 20% of the implanted devices after TAVI are associated with a significant degree of paravalvular leaks, which appear to be associated with a negative clinical outcome. METHODS: A total of 355 patients with severe aortic valvular stenosis (AVS) were treated by TAVI (Corevalve n = 222, Edwards Sapien n = 133). Survival, NT-proBNP and the grade of PVL were quantified up to 12 months after implantation. RESULTS: Technical success rate was 97.8%. Thirty-day mortality was 9.6%. Post-procedural transvalvular aortic regurgitation was seen only in a minority of cases (5%), whereas PVL were frequently observed (grade: <1+ in 58.2%, ≥1-<2 in 33.9%, and ≥2 in 7.9%). There was a clear relation-ship between PVL and adverse outcome (P < 0.001). After a transient increase, NT-proBNP showed a significant decline. Interestingly, a PVL ≥2+ was associated with a much higher rise in NT-proBNP compared to the other groups (P < 0.01), and a post-procedural increase in NT-proBNP by more than 1640 ng L(-1) within 5 days was associated with a significant increase in rate of death (P < 0.01). CONCLUSIONS: TAVI is an efficient treatment option for high-risk patients with severe AVS. The incidence of PVL is an inacceptable clinical problem. Serial measurement of NT-proBNP can be used for risk-stratification in patients with a significant PVL. In general, PVL graded ≥2+ is associated with a dramatically increased 6-month mortality. Therefore, any action to reduce paraprosthetical regurgitation is highly recommended.

Simultaneous Double Clipping Delivery Guide Strategy in Complex Mitral Regurgitation.

The details are reported of a novel treatment strategy using two-clip delivery systems (2CDS) simultaneously, after double trans-septal puncture, for the treatment of severe functional mitral regurgitation. In five individual patients with complex mitral regurgitation, both CDSs were used successfully to titrate for an optimal result. The learning curve and limitations of this particular approach are described.