Impact of frailty on short term outcomes, resource use, and readmissions after transcatheter mitral valve repair: A national analysis.

BACKGROUND: Treatment options for mitral regurgitation range from diuretic therapy, to surgical and interventional strategies including TMVR in high-risk surgical candidates. Frailty has been associated with inferior outcomes following hospitalizations for heart failure and in open cardiac surgery. OBJECTIVE: The purpose of the present study was to evaluate the impact of frailty on clinical outcomes and resource use following transcatheter mitral valve repair (TMVR). METHODS: Adults undergoing TMVR were identified using the 2016-2018 Nationwide Readmissions Database, and divided into Frail and Non-Frail groups. Frailty was defined using a derivative of the Johns Hopkins Adjusted Clinical Groups frailty indicator. Generalized linear models were used to assess the association of frailty with in-hospital mortality, complications, nonhome discharge, hospitalization costs, length of stay, and non-elective readmission at 90 days. Average marginal effects were used to quantify the impact of frailty on predicted mortality. RESULTS: Of 18,791 patients undergoing TMVR, 11.6% were considered frail. The observed mortality rate for the overall cohort was 2.2%. After adjustment, frailty was associated with increased odds of in-hospital mortality (AOR 1.8, 95% CI 1.2-2.6), corresponding to an absolute increase in risk of mortality of 1.1%. Frailty was associated with a 2.7-day (95% CI 2.1-3.2) increase in postoperative LOS, and $18,300 (95% CI 14,400-22,200) increment in hospitalization costs. Frail patients had greater odds (4.4, 95% CI 3.6-5.4) of nonhome discharge but similar odds of non-elective 90-day readmission. CONCLUSIONS: Frailty is independently associated with inferior short-term clinical outcomes and greater resource use following TMVR. Inclusion of frailty into existing risk models may better inform choice of therapy and shared decision-making.

Percutaneous left atrial appendage occlusion: A review of current devices, clinical evidence, patient selection, and post procedural antithrombotic management.

Stroke is a major driver of increased morbidity and mortality in patients with non-valvular atrial fibrillation (NVAF). While systemic oral anticoagulation (OAC) continues to be the mainstay for stroke reduction therapy in patients with NVAF, several barriers prevent the sustained long-term use of OAC, including increased risk of bleeding, non-compliance, cost, drug-drug interactions, and the need for ongoing laboratory testing. Given the need for continued stroke reduction therapies in patients who are intolerant of or non-compliant with OAC, percutaneous left atrial appendage (LAA) occlusion (LAAO) has emerged as a nonpharmacologic alternative to OAC. The development of percutaneous LAAO techniques is based on data suggesting that more than 90% of thrombi in patients with NVAF originate in the LAA. Two percutaneous LAAO devices are currently in widespread clinical use: Watchman (United States and Europe) and the Amplatzer type of devices (Europe); randomized trial data exist only for the Watchman device. Multiple randomized and nonrandomized trials and registries have demonstrated the safety and effectiveness of LAAO in patients who are suitable for short-term anticoagulation using a variety of post-procedural antithrombotic strategies. Ongoing randomized clinical trials on LAAO are focused on OAC-ineligible patients to compare efficacy of LAAO devices against a multitude of antithrombotic options. This review aims to discuss the rationale and evidence for LAAO and post procedural antithrombotic strategies and opportunities for research examination. In addition, we discuss the need for continued investigation of LAAO in populations not well represented in clinical trials or registries, including women, older patients, and underrepresented racial and ethnic groups.

Transcatheter patent arterial duct closure in premature infants: A new technique to ease access to the patent arterial duct, with particular benefit for the tricuspid valve.

BACKGROUND: Transcatheter patent arterial duct (PAD) closure in premature infants has been shown to be feasible. Since our early transcatheter PAD closure procedures in premature infants at Hôpital Necker Enfants Malades, we have changed our technique several times to advance the guidewire through the right heart to avoid tricuspid valve damage. AIM: To describe the technique we have been using since May 2019, to report our results with a particular focus on tricuspid leaks and to analyse the potential mechanisms of tricuspid lesion development with previous methods. METHODS: All premature infants weighing<2kg who underwent transcatheter PAD closure with this new technique were included. Demographic data, procedural data, outcome and procedural complications were reviewed, with particular attention to the occurrence of tricuspid regurgitation. RESULTS: Between May 2019 and May 2020, 33 patients were included. Median gestational age was 25 weeks. Median birth weight and procedural weight were 690g (range 490-1065g; interquartile range [IQR] 620-785g) and 1160g (range 900-1900g; IQR 1030-1300g), respectively. Median age at procedure was 35 (IQR 30-46) days. PAD anatomy was evaluated on transthoracic echocardiography only. The median duct diameter was 3 (IQR 2.5-3.2) mm at the pulmonary end. Success rate was 100% (defined as successful closure without residual shunt). One patient had a renal vein thrombosis, which fully resolved with low-molecular-weight heparin anticoagulation. No tricuspid regurgitation or stenosis of the left pulmonary artery or the aorta was seen. One patient died of a superior caval vein obstruction with bilateral chylothorax related to a central catheter thrombosis 56 days after the procedure, unrelated to the catheter procedure. CONCLUSION: In this prospective study, we describe a new technique to avoid tricuspid valve damage and facilitate delivery of the PAD device.

German Registry for Cardiac Operations and Interventions in Patients with Congenital Heart Disease: Report 2020-Comprehensive Data from 6 Years of Experience.

BACKGROUND: Based on a quality assurance initiative of the German Society for Thoracic and Cardiovascular Surgery (DGTHG) and the German Society for Pediatric Cardiology and Congenital Heart Defects (DGPK), a voluntary registry was founded for assessment of treatment and outcomes of patients with congenital heart disease in Germany. This evaluation by the German Registry for cardiac operations and interventions in patients with congenital heart disease reports the data and the outcome over a 6-year period in patients undergoing invasive treatment. METHODS: This real-world database collects clinical characteristics, in-hospital complications, and medium-term outcome of patients who underwent cardiac surgical and interventional procedures within the prospective, all-comers registry. Patients were followed-up for up to 90 days. RESULTS: In the period from 2013 to 2018, a total of 35,730 patients, 39,875 cases, respectively 46,700 procedures were included at up to 31 German institutions. The cases could be subcategorized according to the treatment intention into 21,027 (52.7%) isolated operations, 17,259 (43.3%) isolated interventions, and 1,589 (4.0%) with multiple procedures. Of these, 4,708 (11.8%) were performed in neonates, 10,047 (25.2%) in infants, 19,351 (48.5%) in children of 1 to 18 years, and 5,769 (14.5%) in adults. Also, 15,845 (33.9%) cases could be allocated to so-called index procedures which underwent a more detailed evaluation to enable meaningful comparability. The mean unadjusted in-hospital mortality of all cases in our registry ranged from 0.3% in patients with isolated interventions and 2.0% in patients with surgical procedures up to 9.1% in patients undergoing multiple procedures. CONCLUSION: This annually updated registry of both scientific societies represents voluntary public reporting by accumulating actual information for surgical and interventional procedures in patients with congenital heart disease (CHD) in Germany. It describes advancements in cardiac medicine and is a basis for internal and external quality assurance for all participating institutions. In addition, the registry demonstrates that in Germany, both interventional and surgical procedures for treatment of CHD are offered with high medical quality.

Arterial duct stent versus surgical shunt for patients with duct-dependent pulmonary circulation: a meta-analysis.

BACKGROUND: Both systemic-pulmonary shunt and arterial duct stent could be the palliation of duct-dependent pulmonary circulation. We aimed to compare the safety and efficacy of the two approaches. METHODS: The PubMed, EMBASE, and Cochrane Library databases were searched through December 2019 for studies comparing stent implantation and surgical shunt in duct-dependent pulmonary circulation. The baseline characteristics included ventricle physiology and cardiac anomaly. The main outcomes were hospital stay and total mortality. Additional outcomes included procedural complications, intensive care unit (ICU) stay, pulmonary artery growth at follow-up, and other indexes. A random- or fixed-effects model was used to summarize the estimates of the mean difference (MD)/risk ratio (RR) with 95% confidence intervals (CIs). RESULTS: In total, 757 patients with duct-dependent pulmonary circulation from six studies were included. Pooled estimates of hospital stay (MD, - 4.83; 95% CI - 7.92 to - 1.74; p < 0.05), total mortality (RR 0.44; 95% CI 0.28-0.70; p < 0.05), complications (RR 0.49; 95% CI 0.30-0.81; p < 0.05) and ICU stay (MD, - 4.00; 95% CI - 5.96 to - 2.04; p < 0.05) favored the stent group. Significant differences were found in the proportions of patients with a single ventricle (RR 0.82; 95% CI 0.68-0.98; p < 0.05) or a double ventricle (RR 1.23; 95% CI 1.07-1.41; p < 0.05) between the stent and shunt groups. Additionally, pulmonary artery growth showed no significant differences between the two groups. CONCLUSION: Arterial duct stent appears to have not inferior outcomes of procedural complications, mortality, hospital and ICU stay, and pulmonary artery growth in selected patients compared with a surgical shunt. TRIAL REGISTRATION: CRD42019147672.

Impact of the COVID-19 pandemic on cardiovascular mortality and catherization activity during the lockdown in central Germany: an observational study.

AIMS: During the COVID-19 pandemic, hospital admissions for cardiac care have declined. However, effects on mortality are unclear. Thus, we sought to evaluate the impact of the lockdown period in central Germany on overall and cardiovascular deaths. Simultaneously we looked at catheterization activities in the same region. METHODS AND RESULTS: Data from 22 of 24 public health-authorities in central Germany were aggregated during the pandemic related lockdown period and compared to the same time period in 2019. Information on the total number of deaths and causes of death, including cardiovascular mortality, were collected. Additionally, we compared rates of hospitalization (n = 5178) for chronic coronary syndrome (CCS), acute coronary syndrome (ACS), and out of hospital cardiac arrest (OHCA) in 26 hospitals in this area. Data on 5,984 deaths occurring between March 23, 2020 and April 26, 2020 were evaluated. In comparison to the reference non-pandemic period in 2019 (deaths: n = 5832), there was a non-significant increase in all-cause mortality of 2.6% [incidence rate ratio (IRR) 1.03, 95% confidence interval (CI) 0.99-1.06; p = 0.16]. Cardiovascular and cardiac mortality increased significantly by 7.6% (IRR 1.08, 95%-CI 1.01-1.14; p = 0.02) and by 11.8% (IRR 1.12, 95%-CI 1.05-1.19; p < 0.001), respectively. During the same period, our data revealed a drop in cardiac catherization procedures. CONCLUSION: During the COVID-19-related lockdown a significant increase in cardiovascular mortality was observed in central Germany, whereas catherization activities were reduced. The mechanisms underlying both of these observations should be investigated further in order to better understand the effects of a pandemic-related lockdown and social-distancing restrictions on cardiovascular care and mortality.

Percutaneous Closure of Patent Ductus Arteriosus in Infants 1.5 kg or Less: A Meta-Analysis.

OBJECTIVE: To investigate technical success and safety of percutaneous patent ductus arteriosus closure in infants ≤1.5 kg. STUDY DESIGN: A systematic review and meta-analysis was performed. Data sources included Scopus, Web of Science, Embase, CINAHL, Cochrane, and PubMed from inception to April 2020. Publications were included if they had a clear definition of the intervention as percutaneous patent ductus arteriosus closure in infants ≤1.5 kg. Data extraction was independently performed by multiple observers. Primary outcome was technical success and secondary outcomes were adverse events (AEs). Subgroup analysis was performed in infants ≤6.0 kg. Data were pooled by using a random-effects model. RESULTS: We included 28 studies, including 373 infants ≤1.5 kg and 69 studies enrolling 1794 infants ≤6.0 kg. In patients ≤1.5 kg, technical success was 96% (95% CI, 93%-98%; P = .16; I2 = 23%). The overall incidence of AE was 27% (95% CI, 17%-38%; P < .001; I2 = 70%) and major AEs was 8% (95% CI, 5%-10%; P = .63; I2 = 0%). There were 5 deaths related to the procedure (2%; 95% CI, 1%-4%; P = .99; I2 = 0%); 4 of these deaths occurred in infants <0.8 kg. The probability of technical failure was inversely related to age at the time of the procedure (OR, 0.9; 95% CI, 0.830-0.974; P = .009). Weight at intervention has decreased over time and procedural success has increased. CONCLUSIONS: Percutaneous patent ductus arteriosus closure is feasible in infants ≤1.5 kg with few major AEs. The procedural success rate is high, despite performing the intervention in smaller patients. PROSPERO REGISTRATION: CRD42020145230.

Impact of Young Age and Gender on Outcomes of Transradial Versus Transfemoral Access Coronary Angiography.

The differential impact of young age and female gender on transradial access (TRA) outcomes remains to be confirmed. The primary objective was to assess the impact of young age and female gender on in-hospital net adverse cardiovascular events (NACE). Among 12 346 patients from the Coronary Angiogram Database of South Australia (CADOSA) Registry, the impact of gender; men (transfemoral access [TFA] 1995, TRA 6168) and women (TFA 1249, TRA 2934), and a median split of age, ≤63 years (TFA 1617, TRA 4727) and >63 years (TFA 1627, TRA 4375) were analyzed on in-hospital outcomes by creating 5 separate propensity-matched cohorts (entire cohort, men, women, ≤63 and > 63 years). Net adverse cardiovascular event reduction with TRA was limited to the >63 years old cohort (odds ratio [OR] = 0.56, 95% CI: 0.34-0.93, P = .02) and women (OR = 0.37, 95% CI: 0.18-0.76, P = .007). In both the age groups and genders, TRA was associated with a lower risk of bleeding and all-cause mortality. On multivariate logistic regression, TRA was associated with a significant reduction in NACE, major bleeding, and mortality in the overall cohort. In conclusion, a reduction in bleeding and mortality was noted with TRA in all the subgroups in this observational study.

Alternative Access Transcatheter Aortic Valve Replacement in Nonagenarians versus Younger Patients.

BACKGROUND: Numerous studies have documented the safety of alternatives access (AA) transcatheter aortic valve replacement (TAVR) for patients who are not candidates for transfemoral or surgical approach. There is a scarcity of studies relating use of AA TAVR in nonagenarian patients, a high-risk, frail group. Our study sought to investigate the clinical outcomes of nonagenarians who underwent AA TAVR for aortic stenosis, with comparison of nonagenarians age ≥90 years with patients age <90 years. METHODS: A cohort study of 171 consecutive patients undergoing AA TAVR (transapical [TA, n = 101, 59%], transaxillary [TAX, n = 56, 33%], transaortic [TAO, n = 11, 6%], and transcarotid [TC, n = 3, 2%]) from 2012 to 2019 was analyzed. Baseline, operative, and postoperative characteristics, as well as actuarial survival outcomes, were compared. RESULTS: AA TAVR patients had decreased aortic valve gradients with no difference detected in nonagenarians and younger patients. Operative mortality was 8% (n = 14; nine TA, three TAO, and two TAX). Compared to younger patients, significantly more nonagenarians were recorded to have new onset atrial fibrillation (7 vs. 5%, p < 0.01*). No significant difference in mortality or postoperative complications, such as stroke, pacemaker requirements, was detected. Actuarial survival at 1 and 5 years was 86 versus 87% (nonagenarians vs younger patients) and 36 versus 22%, respectively, with log-rank = 0.97. CONCLUSION: AA TAVR in nonagenarian patients who are not candidates for transfemoral approach can be efficaciously performed with comparable clinical outcomes to younger patients, age <90 years. Furthermore, some access sites should be avoided when possible; notably TA was associated with increased mortality, stroke, and new onset atrial fibrillation.

Management of atrial fibrillation after transcatheter aortic valve replacement: Challenges and therapeutic considerations.

Atrial Fibrillation (AF) is very common among patients with severe aortic stenosis. Moreover, new onset AF (NOAF) is a frequent finding after Transcatheter Aortic Valve Replacement (TAVR). There is a significant impact of AF on outcomes in patients undergoing TAVR including mortality, thrombo-embolic and bleeding events. There is lack of clear evidence about the optimal management of AF in TAVR patients. This review aims to summarize the epidemiology, predictors, prognosis, therapeutic considerations and challenges in the management of AF in patients undergoing TAVR.

Comparative Safety and Efficacy of Left Atrial Appendage Occlusion with the Watchman Device and Amplatzer Cardiac Plug: Results of the Russian National Registry.

PURPOSE: This multicenter, prospective registry evaluated the comparative safety and efficacy of left atrial appendage occlusion (LAAO) using the Watchman device (WD) and the Amplatzer Cardiac Plug (ACP) in patients with nonvalvular atrial fibrillation (NVAF) in real-world clinical practice in Russia. METHODS: The study included data from 200 consecutive NVAF patients (66.8 ± 7.8 years, 44.5% female, median CHA2DS2VASc 4, median HAS-BLED 3) who had undergone LAAO implantation using WD (n = 108) or ACP (n = 92) from September 2015 to December 2017 in 5 medical centers in Russia. The primary safety endpoint was the procedure-related major adverse events, and the primary efficacy endpoint was the composite of thromboembolic events, device thrombosis, hemorrhagic events, and unexplained death during the 12-month follow-up. RESULTS: Successful LAAO was performed in all 92 (100%) patients with ACP and 105 (97.2%) with WD (p = 0.053). At 12 months, primary safety endpoint occurred in 6.5% of patients in the ACP group with no events in the WD group (6.5% vs. 0%, p = 0.008). During the 12-month follow-up, the primary efficacy endpoint has occurred in 8.3% of patients in the WD group (n = 9) and 1.1% of patients in the ACP group (n = 1) (p = 0.016). CONCLUSIONS: In this multicenter prospective registry, LAA closure with the WD was associated with significantly higher thromboembolic events rate in NVAF patients. Patients, receiving the ACP, had more procedure-related major adverse events. However, further multicenter studies are necessary to evaluate these findings.

Short to medium term outcomes of right ventricular outflow tract stenting as initial palliation for symptomatic infants with complete atrioventricular septal defect with associated tetralogy of Fallot.

OBJECTIVES: To assess the impact of right ventricular outflow tract (RVOT) stenting as the primary palliation in infants with complete atrioventricular septal defect with associated tetralogy of Fallot (cAVSD/TOF). BACKGROUND: Historically, palliation of symptomatic patients with cAVSD/TOF has been achieved through surgical systemic to pulmonary artery shunting. More recently RVOT stenting has evolved as an acceptable alternative in patients with tetralogy of Fallot. METHODS: Retrospective review of all patients with cAVSD/TOF who underwent RVOT stenting as palliation over a 13-year period from two large tertiary referral centers. RESULTS: Twenty-six patients underwent RVOT stenting at a median age of 57 days (interquartile range [IQR] 25.5-106.5). Median weight for stent deployment was 3.7 kg (IQR 2.91-5.5 kg). RVOT stenting improved oxygen saturations from a median of 72% (IQR 70-76%) to 90% (IQR 84-92%), p < .001. There was a significant increase in the median Z-score for both branch pulmonary arteries at median follow-up of 255 days (IQR 60-455). Eight patients required RVOT stent balloon dilatations and 8 patients required re-stenting for progressive desaturation. The median duration between reinterventions was 122 days (IQR 53-294 days). Four patients died during the follow-up period. No deaths resulted from the initial intervention. To date, definitive surgical intervention was achieved in 19 patients (biventricular repair n = 15) at a median age of 369 days (IQR 223-546 days). CONCLUSION: RVOT stenting in cAVSD/TOF is a safe and effective palliative procedure in symptomatic infants, promoting pulmonary artery growth and improving oxygen saturations.

Impact of Massive or Torrential Tricuspid Regurgitation in Patients Undergoing Transcatheter Tricuspid Valve Intervention.

OBJECTIVES: The aim of this study was to assess the clinical outcome of baseline massive or torrential tricuspid regurgitation (TR) after transcatheter tricuspid valve intervention (TTVI). BACKGROUND: The use of TTVI to treat symptomatic severe TR has been increasing rapidly, but little is known regarding the impact of massive or torrential TR beyond severe TR. METHODS: The study population comprised 333 patients with significant symptomatic TR from the TriValve Registry who underwent TTVI. Mid-term outcomes after TTVI were assessed according to the presence of massive or torrential TR, defined as vena contracta width ≥14 mm. Procedural success was defined as patient survival after successful device implantation and delivery system retrieval, with residual TR ≤2+. The primary endpoint comprised survival rate and freedom from rehospitalization for heart failure, survival rate, and rehospitalization at 1 year. RESULTS: Baseline massive or torrential TR and severe TR were observed in 154 patients (46.2%) and 179 patients (53.8%), respectively. Patients with massive or torrential TR had a higher prevalence of ascites than those with severe TR (27.3% vs. 20.4%, respectively; p = 0.15) and demonstrated a similar procedural success rate (83.2% vs. 77.3%, respectively; p = 0.21). The incidence of peri-procedural adverse events was low, with no significant between-group differences. Freedom from the composite endpoint was significantly lower in patients with massive or torrential TR than in those with severe TR, which was significantly associated with an increased risk for 1-year death of any cause or rehospitalization for heart failure (adjusted hazard ratio: 1.91; 95% confidence interval: 1.10 to 3.34; p = 0.022). Freedom from the composite endpoint was significantly higher in patients with massive or torrential TR when procedural success was achieved (69.9% vs. 54.2%, p = 0.048). CONCLUSIONS: Baseline massive or torrential TR is associated with an increased risk for all-cause mortality and rehospitalization for heart failure 1 year after TTVI. Procedural success is related to better outcomes, even in the presence of baseline massive or torrential TR. (International Multisite Transcatheter Tricuspid Valve Therapies Registry [TriValve]; NCT03416166).

Percutaneous large-bore axillary access is a safe alternative to surgical approach: A systematic review.

OBJECTIVES: To systematically review relevant literature regarding cardiovascular outcomes of large-bore axillary arterial access via percutaneous and surgical approaches. BACKGROUND: In patients with severe peripheral arterial disease (PAD) undergoing cardiac interventions, large-bore femoral access may be prohibitive. The axillary artery provides an alternative vascular access for transcatheter aortic valve replacement (TAVR) or mechanical circulatory support. There have been limited comparisons of percutaneous transaxillary (pTAX) approach with the more traditional surgical transaxillary (sTAX) approach. METHODS: Pubmed and Medline databases were queried through January 2019 for studies describing pTAX or sTAX approaches with TAVR or Impella insertion. Primary outcomes were access-related mortality, 30-day mortality, stroke, major vascular complications, and major bleeding. RESULTS: One hundred and fifty five studies were reviewed, with additional unpublished data from 1 institution. Twenty-two studies met the inclusion criteria. Patient data was heterogeneous, with 69% TAVR and 31% Impella use in the pTAX group, and 96% TAVR and 4% Impella use in the sTAX group. There was more cardiogenic shock in the pTAX group. When compared to surgical approach, the percutaneous approach had similar 30-day mortality for TAVR (5.6% vs 4.6%, OR non-significant) and Impella (43.4% vs 38.6%, OR non-significant), similar stroke rates (4.3% vs 4.2%, OR non-significant), similar major vascular complications (2.8% vs 2.3%, OR non-significant) and less major bleeding (2.7% vs 17.9%, OR significant). CONCLUSIONS: Data suggests large-bore pTAX access has similar 30-day mortality, stroke rates, and major vascular complications as sTAX access, with less major bleeding. Additional studies are needed to validate results.

Transcatheter therapies for tricuspid valve regurgitation.

: Tricuspid regurgitation, either isolated or associated with left-valve disease, has a strong impact on outcome. Surgical treatment of tricuspid regurgitation has increased in recent years, but in-hospital mortality remains high probably due to the risk profile of the recipients. As a consequence, most of the patients with severe tricuspid regurgitation, especially if isolated, remain untreated. Transcatheter tricuspid valve interventions are rapidly spreading as alternative options to open-heart procedures fulfilling this important unmet need. Although patient selection and timing of intervention are unclear, many devices have been developed in recent years for both repair and replacement of tricuspid valve. Repair tools can be targeted to leaflets or annulus. Replacement devices include heterotopic and orthotropic systems. The aim of this review is to report possible indications and summarize current data about the different devices available for transcatheter tricuspid valve interventions.

Predictors of Outcomes Following Transcatheter Edge-to-Edge Mitral Valve Repair.

Transcatheter edge-to-edge mitral valve repair is a viable alternative to surgery in patients with severe mitral regurgitation and high surgical risk. Yet the specific group of patients who would optimally benefit from this therapy remains to be determined. Selection of patients for transcatheter strategy is currently based on surgical prognostic scores and technical feasibility. Meanwhile, various clinical, anatomic, and procedural factors have been recently recognized as predictors of adverse outcomes following transcatheter edge-to-edge mitral valve repair, including device failure, recurrent mitral regurgitation, and mortality. Integration of these prognostic factors in the decision-making process of the heart team might improve patient management and outcomes. Herein, the authors review the different factors related to symptomatic status, comorbidity, serum biomarkers, echocardiographic findings, and procedural technique that have been identified as independent predictors of adverse outcome following transcatheter edge-to-edge mitral valve repair and discuss their potential application in everyday clinical practice.

Munich Comparative Study: Prospective Long-Term Outcome of the Transcatheter Melody Valve Versus Surgical Pulmonary Bioprosthesis With Up to 12 Years of Follow-Up.

BACKGROUND: Percutaneous pulmonary valve implantation (PPVI) has become an important treatment of right ventricular outflow tract dysfunction. Studies directly comparing the long-term outcome of PPVI with the Melody valve to surgical pulmonary valve replacement (SPVR) are lacking. METHODS: All patients treated with PPVI with the Melody valve and SPVR between January 2006 and December 2018 in our center were enrolled into a database and investigated with a standard follow-up protocol. The current study compares the outcomes in means of survival, reinterventions, infectious endocarditis, and performance of the valves. RESULTS: The study included 452 patients, of whom 241 were treated with PPVI with the Melody valve and 211 patients with SPVR with different types of valves. Median follow-up time was 5.4 years (3 months to 12.5 years), and the total observation was 2449 patient-years. Estimated survival after 10 years was 94% in the Melody group and 92% in the SPVR group (P=0.47). There was no difference in the estimated survival free of surgery on the implanted valve at 10 years (Melody, 87%, versus SPVR, 87%; P=0.54) or in the survival with the originally implanted pulmonary valve (Melody group, 80%; SPVR group, 73%; P=0.46) between both groups. The annualized incidence of infective endocarditis was 1.6% in the Melody group and 0.5% in the SPVR group, and the estimated survival free of endocarditis did not differ significantly between groups (Melody group, 82%; SPVR group, 86%; P=0.082). Survival free of valve replacement because of infective endocarditis was comparable between both groups (Melody, 88%; SPVR, 88%; P=0.35). CONCLUSIONS: PPVI with the Melody valve and SPVR provides similar survival, freedom of reinterventions, and infective endocarditis with or without the need of replacement of the pulmonary valve. Being less invasive, PPVI should be considered a method for treatment for patients with dysfunctional right ventricular outflow tracts.

Impact of obesity on adverse in-hospital outcomes in patients undergoing percutaneous mitral valve edge-to-edge repair using MitraClip® procedure - Results from the German nationwide inpatient sample.

BACKGROUND AND AIM: The number of percutaneous edge-to-edge mitral regurgitation (MR) valve repairs with MitraClip® implantations increased exponentially in recent years. Studies have suggested an obesity survival paradox in patients with cardiovascular diseases. We investigated the influence of obesity on adverse in-hospital outcomes in patients with MitraClip® implantation. METHODS AND RESULTS: We analyzed data on characteristics of patients and in-hospital outcomes for all percutaneous mitral valve repairs using the edge-to-edge MitraClip®-technique in Germany 2011-2015 stratified for obesity vs. normal-weight/over-weight. The nationwide inpatient sample comprised 13,563 inpatients undergoing MitraClip® implantations. Among them, 1017 (7.5%) patients were coded with obesity. Obese patients were younger (75 vs.77 years,P < 0.001), more often female (45.4% vs.39.5%,P < 0.001), had more often heart failure (87.1% vs.79.2%,P < 0.001) and renal insufficiency (67.0% vs.56.4%,P < 0.001). Obese and non-obese patients were comparable regarding major adverse cardiac and cerebrovascular events (MACCE) and in-hospital death. The combined endpoint of cardio-pulmonary resuscitation (CPR), mechanical ventilation and death was more often reached in non-obese than in obese patients with a trend towards significance (20.6%vs.18.2%,P = 0.066). Obesity was an independent predictor of reduced events regarding the combined endpoint of CPR, mechanical ventilation and death (OR 0.75, 95%CI 0.64-0.89,P < 0.001), but not for reduced in-hospital mortality (P = 0.355) or reduced MACCE rate (P = 0.108). Obesity class III was associated with an elevated risk for pulmonary embolism (OR 5.66, 95%CI 1.35-23.77,P = 0.018). CONCLUSIONS: We observed an obesity paradox regarding the combined endpoint of CPR, mechanical ventilation and in-hospital death in patients undergoing MitraClip® implantation, but our results failed to confirm an impact of obesity on in-hospital survival or MACCE.