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Post-myocardial infarction ventricular septal rupture (MI-VSR) remains a dreadful complication with dismal prognosis. Surgical repair is the primary treatment strategy, whereas the role of heart transplantation (HT) as a primary option in MI-VSR is limited to case reports (CRs). We performed a systematic review of CRs to describe in-hospital mortality, and survival at 6 and 12 months in adult patients with MI-VSR treated with HT as a primary or bailout strategy. We performed a comprehensive search of Web of Science, PubMed, and Ovid Medline. The last search was completed on March 10, 2020. An aggregated score based on the CARE case report guideline was used to assess the quality of the CRs. We included CRs that described adult patients with MI-VSR treated with HT as a primary or bailout strategy. A total of 14 CRs between 1994 and 2015 were included, retrieving and analyzing the characteristics of 17 patients. A total of 12 patients underwent HT, with HT being the primary strategy in 8 patients and a bailout strategy for 4 patients following initial surgical repair, while 5 patients died awaiting HT under mechanical circulatory support (MCS), accounting for the total in-hospital mortality of this series (29%). Regarding long-term outcomes, 6 patients were reported to be alive at 6 months and 1 year after HT, while information was missing in the remaining 6 patients. In conclusion, HT supported by the use of temporary and durable MCS as a bridge to HT could be a feasible primary or bailout strategy to reduce the high in-hospital mortality of patients with MI-VSR. more...

OBJECTIVESRepair outcomes of tricuspid regurgitation (TR) associated with ischaemic mitral regurgitation (IMR) are inferior to functional TR in terms of TR recurrence and right ventricular (RV) reverse remodelling. Our objective is to analyse right versus left heart reverse remodelling after surgery for IMR-associated TR.METHODSFrom 2001 to 2011, 568 patients with severe IMR underwent mitral valve surgery (repair 87%, replacement 13%), and 131 had concomitant tricuspid valve repair. Median follow-up was 3.0 years; 25% of living patients were followed up for 6.3 years. Longitudinal analysis of 1527 follow-up echocardiograms was performed to assess ventricular reverse remodelling and function.RESULTSUnlike the left heart, the right heart failed to reverse remodel (failed to recover ventricular function or halt dilatation). During follow-up after surgery, the right ventricle continued to dilate while the left ventricle regressed in size. RV ejection fraction decreased (46% at 1 month and 44% at 5 years), while left ventricular ejection fraction increased (33% and 37%, respectively). RV strain showed early (−11% at 1 month) and late (−12% at 5 years) dysfunction. Patients who underwent tricuspid valve repair had worse RV function. Mitral regurgitation remained stable after surgical intervention, and TR gradually recurred (37% moderate, 20% severe at 7 years).CONCLUSIONSSurgical treatment of IMR and TR along with revascularization failed to induce reverse remodelling of the right heart. These findings warrant further investigations to identify optimal timing and approach of intervention for IMR-associated TR with respect to RV remodelling. more...

The aim of this registry was to evaluate the feasibility and safety of transcatheter tricuspid valve implantation (TTVI) in patients with extreme surgical risk.Isolated tricuspid regurgitation (TR) surgery is associated with high in-hospital mortality.Thirty consecutive patients (mean age 75 ± 10 years; 56% women) from 10 institutions, with symptomatic functional TR, had institutional and notified body approval for compassionate use of the GATE TTVI system. Baseline, discharge, and 30-day follow-up echocardiographic data and procedural, in-hospital, and follow-up clinical outcomes were collected.At baseline, all patients had multiple comorbidities, severe or greater TR, and reduced baseline right ventricular function. Technical success was achieved in 26 of 30 patients (87%). Device malpositioning occurred in 4 patients, with conversion to open heart surgery in 2 (5%). Of those who received the device, 100% had reductions in TR of ≥1, and 75% experienced reductions of ≥2 grades, resulting in 18 of 24 of patients (76%) with mild or less TR at discharge. All patients had mild or less central TR. There was continued improvement in TR grade between discharge and 30 days in 15 of 19 patients (79%). In-hospital mortality was 10%. At mean follow-up of 127 ± 82 days, 4 patients (13%) had died. Of patients alive at follow-up, 62% were in New York Heart Association functional class I or II, with no late device-related adverse events.Compassionate treatment of severe, symptomatic functional TR using a first-generation TTVI device is associated with significant reduction in TR and improvement in functional status with acceptable in-hospital mortality. Further studies are needed to determine the appropriate patient population and long-term outcomes with TTVI therapy. more...

Background Little is known about graft patency after coronary artery bypass grafting (CABG) performed in patients on dialysis. Our aim was to assess patency of internal thoracic artery (ITA) grafts and saphenous vein grafts (SVGs) in these patients. Methods From 1/1997 to 1/2018, 500 patients on dialysis underwent primary CABG with or without concomitant procedures at Cleveland Clinic, 40 of whom had 48 postoperative angiograms for recurrent ischemic symptoms. Complete follow-up was obtained on all but 1 patient lost to follow-up 1 y after CABG. Thirty-six ITA grafts and 65 SVGs were evaluable for stenosis and occlusion. Results Two of 40 patients (5%) had emergency CABG; 3 (7.5%) with calcified aortas had a change in operative strategy to avoid ascending aortic manipulation, 2 (5%) had poor conduit quality, and 12 (30%) had severe diffuse atherosclerotic disease with calcification of the coronary targets causing technical difficulties. Thirty-three patients (82%) were bypassed with an in situ ITA and 3 (7.5%) had a free ITA graft. Three of 36 ITA grafts were occluded at 0.78, 1.8, and 9.4 y (too few to model). SVG patency was 52% and 37% at 1 and 2 y, respectively. Conclusions Among patients on dialysis who underwent CABG, coronary angiography for ischemic symptoms in a select subset revealed that SVG patency was lower than expected from published reports in the general CABG population and may contribute to the poor prognosis of this cohort. Further work is needed to guide graft selection and improve graft patency in dialysis patients. more...

Functional tricuspid regurgitation (TR) develops secondary to annular dilation and leaflet tethering as a result of right ventricular remodeling. Invasive surgery for isolated TR is rarely performed due to high inpatient mortality. Transcatheter tricuspid valve intervention is an appealing solution but is challenging as crucial structures are closely related to the tricuspid valve, and intracardiac devices pose further challenges to device delivery and implantation. more...

Background Transcatheter aortic valve implantation operators have adapted to a less invasive technique by foregoing the use of general anaesthesia and transoesophageal echocardiography. This is known as a ‘minimalist approach’. This approach has yet to be explored in transcatheter mitral valve replacement (TMVR). Two patients with high perioperative risk underwent TMVR using only monitored conscious sedation (CS) and intracardiac echocardiography (ICE). Case summary The patients were symptomatic and required treatment of severe mitral regurgitation and severe mitral stenosis in a mitral valve ring and prosthetic mitral valve, respectively. With the use of an antegrade transseptal approach, the procedure was conducted under CS using ICE only. After placement of the prosthetic mitral valve, the valve was assessed by advancing the ICE catheter through the interatrial septal defect and no significant paravalvular leak occurred. In one case, ad hoc treatment of right to left shunting was successfully pursued. Valve function was excellent immediately and at 24 h after implantation and resulted in significant haemodynamic improvement. Conclusion With more TMVR cases being conducted, the ‘minimalist approach’ with CS and ICE may be considered in selected cases. more...

Background: Staphylococcus aureus prosthetic valve endocarditis (PVE) is resistant to antimicrobial therapy and commonly associated with tissue invasion, which necessitates complex high risk surgical intervention for cure. Hypothesis: S. aureus virulence in infective endocarditis (IE) is dynamic and changes upon colonizing cardiac valves from blood stream. Methods: Six patients undergoing cardiac surgery for left-sided S. aureus IE, 3 native (NVE) and 3 PVE, were included in this study. Vegetation samples were collected during surgery as well as corresponding blood culture isolates during S. aureus bacteremia. Total RNA was extracted from all samples and underwent mRNA sequencing for transcriptomic analysis of S. aureus . Data was pooled into STAR aligner and gene expression related to virulence factors was compared between different groups (Deseq2; p-value < 0.05 for statistical significance). Results: In NVE vegetations, S. aureus showed an increased expression of genes associated with biofilm formation, cell division, and metabolic activity, when compared to blood culture isolates (e.g. rsmA , agrB , dnaK , clpB , ezrA , fusA , ftsZ , adh , pstS , qoxA ). S. aureus isolated from blood cultures had significantly higher expression of clfA (encoding for clumping factor A) compared to cardiac vegetations. Interestingly, in PVE vegetations, S. aureus had a significant higher expression of aur (encoding for metalloprotease aureolysin) compared to corresponding blood culture isolates or NVE vegetations. Aureolysin is an important virulence factor responsible for immune evasion and toxin production. Conclusions: In clinical IE, S. aureus up-regulates genes responsible for biofilm formation when attached to cardiac valves. Planktonic S. aureus cells in the blood stream express clfA , which could bind to fibrinogen to clump within platelet network to form vegetations. On prosthetic valves, S. aureus expresses aureolysin, which could function to evade the host immune response and promote destruction of cardiac tissues. These novel in-vivo findings provide explanations for S. aureus IE pathophysiology that warrant further investigation. more...

High volume extracorporeal membrane oxygenation (ECMO) centers have developed mobile ECMO programs in recent years to facilitate the implementation of ECMO support at hospitals with lower capabilities, and transfer these patients for further care. We report a case of mobile ECMO on a patient with coronavirus disease 2019‐related acute respiratory distress syndrome, and discuss the potential application in the current severe acute respiratory syndrome coronavirus 2 pandemic. more...

A variety of fenestrated vascular plugs have been used to seal paravalvular leaks with meaningful success; however, incomplete closure and refractory hemolysis remains a common problem. We describe the feasibility and rationale of their first experience using a nonfenestrated Cardioform Septal Occluder (Gore Medical, Flagstaff, Arizona) to treat a giant mitral paravalvular leak. (Level of Difficulty: Advanced.), Graphical abstract, A variety of fenestrated vascular plugs have been used to seal paravalvular leaks with meaningful success; however, incomplete closure and refractory… more...

The importance of a coronary artery, based on the myocardial mass it perfuses, is well documented, but little is known about the importance of a vessel that has been bypassed and its effect on survival in the context of bilateral internal thoracic artery (BITA) grafting.This study determined the effect of a dominant left anterior descending (LAD) artery and important non-LAD targets on outcomes after BITA grafting.From January 1972 to January 2011, of 6,127 patients who underwent BITA grafting, 2,551 received 1 ITA grafted to the LAD and had an evaluable coronary angiogram. A dominant LAD was defined as one that was wrapped around the left ventricular apex. Non-LAD targets were graded based on their terminal reach toward the apex: important:75% (n = 1,698); and less important: ≤75% (n = 853). Mean follow-up was 14 ± 8.7 years. Multivariable analysis was performed to identify risk factors for time-related mortality.A dominant LAD was present more frequently in patients with less important additional targets (51% vs. 35%; p 0.0001). A total of 179 patients (7.0%) received a second ITA to multiple targets, 77 (43%) of which were to multiple important target vessels. Unadjusted late survival was similar regardless of degree of importance of the second ITA target-77% at 15 years (p = 0.70) for the important and less important targets, respectively. In the multivariable model, grafting the second ITA to multiple important targets was associated with better long-term survival (p = 0.005). In patients with a nondominant LAD, a second ITA grafted to a less important artery was associated with higher risk of operative mortality (2.4% vs. 0.51%; p = 0.007). A saphenous vein graft to an important or less important target did not influence long-term survival.In BITA grafting, bypassing multiple important targets to maximize myocardium supplied by ITAs improved long-term survival. In patients with a nondominant LAD, selecting an important target for the second ITA lowered operative mortality. more...

BACKGROUND AND AIM To compare outcomes of patients treated with inhaled epoprostenol and low tidal volume ventilation during cardiopulmonary bypass with those who did not receive this medication in the operating room at all, and those who received it as a rescue therapy at the end of the case. METHODS Retrospective chart review between 2014 and 2017, follow-up included the entire hospital stay. RESULTS Seventy-one patients were included, and mean age was 54 years. 78.9% of the patients were male. Procedures included 96% (n = 68) aortic valve replacement, 28% (n = 20) reconstruction of the intravalvular fibrosa, and 13% (n = 9) repair of an endocarditis-related intracardiac fistula. Patients who received epoprostenol (iEpo) (treatment and rescue groups), when compared with the control group had more intra-aortic balloon pump placement (23% vs 2.5%, P = .018), open chest after surgery (32% vs 7.5%, P = .012), and duration of mechanical ventilation (8.3 ± 2.7 vs. 2.4 ± 0.4 days, P = 0.01). There was no significant difference between the two groups in terms of extracorporeal circulatory support (6.5% vs 2.5%, P = .577) and hospital death (13% vs 10%, P = .72). In a subanalysis, hospital death and duration of mechanical ventilation were higher in the recue group when compared with the treatment group (P = .004 and .056, respectively). CONCLUSIONS Prophylactic application of iEpo with low tidal volume ventilation for an anticipated complex endocarditis operation may contribute to favorable outcome when compared with postoperative epoprostenol rescue. more...

BACKGROUND AND AIM Cardiogenic shock (CS) withholds a significantly high mortality rate between 40% and 60% despite advances in diagnosis and medical/surgical intervention. To date, machine learning (ML) is being implemented to integrate numerous data to optimize early diagnostic predictions and suggest clinical courses. This systematic review summarizes the area under the curve (AUC) receiver operating characteristics (ROCs) accuracy for the early prediction of CS. METHODS A systematic review was conducted within databases of PubMed, ScienceDirect, Clinical Key/MEDLINE, Embase, GoogleScholar, and Cochrane. Cohort studies that assessed the accuracy of early detection of CS using ML software were included. Data extraction was focused on AUC-ROC values directed towards the early detection of CS. RESULTS A total of 943 studies were included for systematic review. From the reviewed studies, 2.2% (N = 21) evaluated patient outcomes, of which 14.3% (N = 3) were assessed. The collective patient cohort (N = 698) consisted of 314 (45.0%) females, with an average age and body mass index of 64.1 years and 28.1 kg/m2 , respectively. Collectively, 159 (22.8%) mortalities were reported following early CS detection. Altogether, the AUC-ROC value was 0.82 (α = .05), deeming it of superb sensitivity and specificity. CONCLUSIONS From the present comprehensively gathered data, this study accounts the use of ML software for the early detection of CS in a clinical setting as a valid tool to predict patients at risk of CS. The complexity of ML and its parallel lack of clinical evidence implies that further prospective randomized control trials are needed to draw definitive conclusions before standardizing the use of these technologies. BRIEF SUMMARY The catastrophic risk of developing CS continues to be a concern in the management of critical cardiac care. The use of ML predictive models have the potential to provide the accurate and necessary feedback for the early detection and proper management of CS. This systematic review summarizes the AUC-ROCs accuracy for the early prediction of CS. more...

OBJECTIVE This study aimed to examine the cumulative experience of peri-device leak (PDL) closure following left atrial appendage (LAA) closure. BACKGROUND The management of PDL following LAA closure remains controversial. While PDL closure has been proposed, procedural features and clinical outcomes have not been well established. METHODS A systematic review of all published cases of PDL closure with available anatomical, procedural, and clinical outcomes was performed. RESULTS We identified 18 indexed publications and 110 cases between April 2013 and March 2020. 71 patients (mean age 72 ± 8 yrs), met study criteria and were included. PDL closure was most common in males, bilobar LAA morphology, and after Watchman procedures. The mean PDL size was 7.6 ± 5.8 mm (range 2-26 mm). Leaks were classified according to size: small ( more...

Aortic dissection (AD) is an uncommon but life-threatening condition associated with high morbidity and mortality. Hypertension (HTN) and hyperlipidemia (HLD) are common modifiable risk factors.Since bariatric surgery is associated with remission of obesity-related co-morbidities, we hypothesize that surgical weight loss might be protective against this feared aortic pathology.A cross-sectional analysis was performed using the National Inpatient Sample database from 2010 to 2015.The treatment group included bariatric patients and the control group patients with obesity (body mass index [BMI] ≥ 35kg/mA total of 2,300,845 patients were identified (2,004,804 controls and 296,041 cases). The mean (SEM) age was 54.4 (.05) versus 51.9 (.05) years, for the control and treatment groups, respectively (P.0001). Bariatric patients posed a significantly lower prevalence of type 2 diabetes (T2D), HTN, HLD, aortic aneurysm, and bicuspid aortic valve (P.0001) than control subjects. In the control group, 1411 individuals (.070%) had AD, whereas only 94 patients (.032%) in the bariatric surgery group had such diagnosis (P.0001). The MLRA showed that non-bariatric obese patients had a significantly higher likelihood of suffering from AD (OR = 1.8 [95%CI 1.44-2.29] P.0001). Considering different age groups, bariatric surgery was found to be less associated with admission for AD for individuals below and above 40 years of age (OR = 2.95 [95%CI 1.09-7.99] P = .0345) and (OR = 1.75 [95%CI 1.38-2.22] P.0001), respectively.Bariatric surgery could be a protective factor against aortic dissection and should be considered in patients with obesity and risk factors for this cardiovascular complication. more...

High volume ECMO centers have developed mobile ECMO programs in recent years to facilitate implementation of ECMO support at hospitals with lower capabilities, and transfer these patients for further care. We report a case of mobile ECMO on patient with COVID-19 related ARDS, and discuss the potential application in current SARS-CoV-2 pandemic. more...

There is a recent rise in percutaneous therapies for the tricuspid valve. Due to the innovative nature of these procedures and the complex anatomy of the tricuspid valve, procedural planning often relies on 3-dimensional (3D) printing. Whereas contrast-enhanced 4-dimensional (4D) computed tomography more...

Background: The purpose of this study was to perform a systematic review and pooled analysis to evaluate 30-day and 1-year outcomes of transcatheter mitral valve-in-valve (VIV) and valve-in-ring (VIR) procedures. Data from the Valve-in-Valve Data Registry revealed that there were several safety and efficacy concerns, although procedural success was achieved in most cases. Methods: Studies reporting data on either mitral VIV and/or VIR with at least five patients were pooled using weighted proportional analysis. Results: The 30-day pooled estimate of all-cause mortality in the mitral VIV group was 7%, valve embolization, 5%, stroke, 3%, and major bleeding, 9%. At 1 year the all-cause mortality was 11%, valve thrombosis, 10%, stroke, 6%, and major bleeding, 16%. In the mitral VIR group, the 30-day pooled estimate for all-cause mortality was 8%, renal failure, 11%, valve embolization, 3%, and left ventricular outflow tract obstruction, 10% and at 1 year the all-cause mortality was about 22%. Conclusions: Mitral VIV and VIR procedures are safe and feasible in high risk surgical candidates. The long-term safety and efficacy data beyond 1 year for both mitral VIV and VIR need to be established. more...

Background: It is unclear whether moderate or less functional tricuspid regurgitation (TR) should be repaired during surgery for degenerative mitral valve (MV) disease. We studied the natural course of unaddressed moderate or less TR and identified risk factors for TR progression after surgery for degenerative MV disease. Methods: From 2001 to 2011, 2,982 patients with isolated degenerative MV disease and no evidence of coronary artery disease underwent MV surgery. To generate an enriched sample of patients with TR, by random selection 200 patients without TR, 197 with mild TR, and 177 with moderate TR were studied. A total of 1,150 echocardiograms were available for longitudinal analysis of TR progression after surgery in 550 of these 574 patients. Results: Overall prevalence of severe TR was 1.1%, 2.2%, 3.6%, and 4.4% by 1, 3, 5, and 7 years, respectively. Patients with moderate preoperative TR were more likely to progress to severe TR by 7 years (8.6%) than those with mild TR (3.2%) or no TR (1.3%) preoperatively (p p = 0.03), shorter right ventricular base-to-apex length (p = 0.0004), smaller tethering area (p = 0.01), older age, and preoperative heart failure. During follow-up, no patient underwent TV intervention. Conclusion: Routine repair of moderate or less functional TR during surgery for degenerative MV disease does not appear to be warranted, because progression to severe TR is uncommon. Instead, we suggest a tailored approach, reserving TR repair during surgery for degenerative MV disease for patients with known risk factors. more...

Tricuspid regurgitation is a common finding in patients with left-sided valvular or myocardial disease, often being a marker for late-stage chronic heart failure with a grim prognosis. Howe...

Tricuspid regurgitation (TR) is a common entity, most commonly functional in nature due to right-sided dysfunction in the setting of concomitant cardiac disease or pulmonary hypertension. Patients living with TR often experience numerous limitations as a result of right-sided heart failure symptoms, including functional decline, frequent hospitalizations, liver failure, and kidney failure. Furthermore, patients with significant TR demonstrate worse survival, although a cause-and-effect relationship has not been proven. For patients with a degenerated surgical bioprosthesis or valve ring, placement of a transcatheter aortic valve prosthesis in a valve-in-valve or valve-in-ring fashion may provide symptomatic benefit. For patients with native valve regurgitation, novel devices for treatment are currently under development. more...

ObjectivesA substantial number of patients with severe tricuspid regurgitation (TR) and congestive heart failure (CHF) are medically managed without undergoing corrective surgery. We sought to assess the characteristics and outcomes of CHF patients who underwent tricuspid valve surgery (TVS), compared with those who did not.MethodsRetrospective observational study involving 2556 consecutive patients with severe TR from the Cleveland Clinic Echocardiographic Database. Cardiac transplant patients or those without CHF were excluded. Survival difference between patients who were medically managed versus those who underwent TVS was compared using Kaplan-Meier survival curves. Multivariate analysis was performed to identify variables associated with poor outcomes.ResultsAmong a total of 534 patients with severe TR and CHF, only 55 (10.3%) patients underwent TVS. Among the non-surgical patients (n=479), 30% (n=143) had an identifiable indication for TVS. At 38 months, patients who underwent TVS had better survival than those who were medically managed (62% vs 35%; pConclusionAlthough corrective TVS is associated with better outcomes in patients with severe TR and CHF, a substantial number of them continue to be medically managed. However, since the reasons for patients not being referred to surgery could not be ascertained, further randomised studies are needed to validate our findings before clinicians can consider surgical referral for these patients. more...

Patients with isolated functional or recurrent tricuspid regurgitation are often considered high risk and denied surgery. There has been growing experience for transcatheter tricuspid valve implantation through valve-in-valve or valve-in-ring, and recently, but to a lesser extent, in native annulus. The NaviGate is a novel self-expanding valved-stent designed with unique features to treat tricuspid regurgitation, particularly, in the settings of severely dilated tricuspid annulus. Herein, we present the innovation facets and clinical application of the NaviGate system. more...

Introduction Percutaneous femoral access is the preferred access route for transcatheter aortic valve replacement (TAVR). The majority of experienced TAVR centers use two 6F Perclose ProGlide™ devices to close the primary vascular access site, deployed prior to upsizing sheath size with closure completed at the end of the case (the "preclose" approach). A strategy of utilizing a single Perclose device to preclose may have advantages including fewer complications, complexity, and cost, but the safety of this is unknown. This study examines in the safety and efficacy of using a single Perclose versus double Perclose for perclosure of large bore access during TAVR. Methods Patients undergoing Transfemoral (TF) TAVR from January 2014 to December 2017 within the Cleveland Clinic Aortic Valve Center were identified. A retrospective review of medical charts was conducted. Vascular complications were defined according to the VARC-2 criteria. Results A total of 740 patients were included; 487 (65.8%) received a single Perclose device while 253 (34.2%) received double Perclose devices. Baseline characteristics were similar with no differences between the single versus double Perclose groups, respectively. The access sheath size was similar in both groups with (14, 16, and 18 F) being the most common sizes utilized. Of the total 487 patients with single Perclose, 75.6% needed additional closure device (AngioSeal). With double Perclose strategy, additional closure device (AngioSeal) was used in 40.3% patients with 470 (63.5%) patients being successfully perclosed. Vascular complication rates including hematoma, stenosis requiring stenting, pseudoaneurysm, and other major vascular complications were similar between both groups. Conclusion Single 6F ProGlide use for preclosure is a safe strategy for TF TAVR using the S3 valve. Additional closure device was not needed in almost one-quarter of the patients. When necessary, residual bleeding can be controlled with the AngioSeal Device at the end of the procedure. This single device preclose strategy can help to reduce the cost of TAVR procedure without increasing risk. more...

Background There has been an increase in the prevalence of drug abuse ( DA ) in the national opioid epidemic. With increasing DA , there is an increased risk of infective endocarditis ( IE ). There are limited recent data evaluating national trends on the incidence and geographical distribution of DA ‐ IE . We aim to investigate those numbers as well as the determinants of outcome in this patient population. Methods and Results Hospitalized patients with a primary or secondary diagnosis of IE based on the International Classification of Diseases , Ninth and Tenth Revisions (ICD‐9, ICD‐10) were included. We described the national and geographical trends in DA ‐ IE . We also compared DA ‐ IE patients’ characteristics and outcomes to those with IE , but without associated drug abuse (non‐ DA ‐ IE ) using Poisson regression models. Incidence of DA ‐ IE has nearly doubled between 2002 and 2016 All US regions were affected, and the Midwest had the highest increase in DA ‐ IE hospitalizations (annual percent change=4.9%). Patients with DA ‐ IE were younger, more commonly white males, poorer, had fewer comorbidities, and were more likely to have human immunodeficiency virus, hepatitis C, concomitant alcohol abuse, and liver disease. Their length of stay was longer (9 versus 7 days; P P P Conclusions DA ‐ IE is rising at an alarming rate in the United States. All regions of the United States are affected, with the Midwest having the highest increase in rate. Young‐adult, poor, white males were the most affected. more...

Objective Redo sternotomy in patients with arterial cardiac structures adherent to the sternum carries a risk of catastrophic bleeding. In some of those cases, particularly if they have undergone multiple previous operations deep hypothermic circulatory arrest alone may not provide sufficient time for a controlled dissection.. Methods We present a series of 6 cases at risk for exsanguination during sternal reentry successfully reoperated using percutaneous cardioplegic cardiac arrest induced prior to completed sternal re-entry to avoid or minimize the hypothermic circulatory arrest time. Results All patients survived their complex operations. Conclusions Percutaneous cardioplegic arrest allows safer repeat sternotomy in patients with arterial cardiac structures adherent to the sternum. more...

Objectives The aim of this study was to compare the rate and trend of vascular complications when placing a second arterial sheath in the contralateral femoral artery during transcatheter aortic valve replacement (TAVR) unilaterally versus bilaterally. Background Vascular complications occur in approximately 5% to 8% of TAVR procedures. Many operators place a second arterial sheath in the contralateral femoral artery to perform aortic root angiography. The authors surmised that placing the second sheath ipsilateral and distal to the delivery sheath would be an easier option with similar safety. Methods The Cleveland Clinic Aortic Valve Center TAVR database was accessed, and data for patients undergoing transfemoral TAVR (TF-TAVR) from January 2014 to December 2017 were analyzed retrospectively. The primary outcome was the rate of peripheral vascular complications. Results A total of 1,208 patients who underwent TF-TAVR were included in this study. One thousand seven patients (83.36%) underwent bilateral femoral access, and 201 patients (16.64%) underwent TF-TAVR using a unilateral femoral approach. Over the study duration, use of the unilateral access approach trended upward significantly, reaching 43.7% of total cases in 2017. A gradual decline in access site–related vascular complications was observed, from 13.7% in 2014 to 7.4% in 2017. After propensity-score matching, peripheral vascular complications were similar between bilateral access and unilateral access (10.8% vs. 8.6%) (p = 0.543). Conclusions There was a significant decline in vascular complications from 2014 to 2017. Unilateral-access TF-TAVR provided similar safety compared with bilateral-access TF-TAVR and is a more accessible approach for managing access site–related complications and possibly achieving better patient satisfaction. more...

Introduction Fluctuations in hormonal levels can alter cardiac myocytes at the cellular level, often resulting in deterioration of cardiac function. Endocrine cardiomyopathies have been described in the setting of hypo/hyperthyroidism, GH deficiency, acromegaly, and diabetes. However, it is rarely described in the setting of autoimmune polyglandular syndrome (APS). Case Report A 19 year-old male with a PMH of APS associated with hypothyroidism and adrenal insufficiency. He initially presented to an outside facility after a syncopal episode. Initial workup revealed a TSH of 70 and he was started on appropriate therapy. Soon after admission, he developed acute hypoxemic respiratory failure requiring urgent intubation. Due to severe pulmonary edema, an echo was obtained which revealed a severely decreased EF of 20%. An Impella CP® and Swan Ganz catheter were placed for management of cardiogenic shock. Due to persistent clinical deterioration with worsening renal and hepatic function, he underwent RPella® placement. Two days later he was transferred to our hospital for consideration of advanced Heart Failure therapies. Upon transfer, he was maintained on appropriate hormone therapies by endocrinology. An endomyocardial biopsy was unrevealing. We started low dose diuretics and noted marked improvement in right sided parameters with improving central venous pressures and resolving transaminitis. Repeat echo revealed normal right ventricular systolic function. The RPella® was then weaned off and electively removed. The Impella CP® device was weaned daily as per protocol. EF improved to 30% on repeat echo. Cardiac MRI was nonspecific. He was downgraded from ICU status after tolerance of comprehensive guideline based medical therapy. Summary Previously described is a 32 year old male with a history of APS who developed severe biventricular failure requiring inotropic support, counterpulsation, mechanical circulatory support (MCS), and ultimately cardiac transplantation. Though our patient presented to us in a highly compromised state, the use of MCS helped bridge the patient to a recovery in myocardial performance while undergoing hormonal replacement. To our knowledge, this is the first case of its nature and highlights the possibility of temporary MCS in APS-associated cardiomyopathy, and in turn, can be useful in other secondary cardiomyopathies. more...

Purpose Patients are the best source of information about how they feel and how care affects them. Patient-reported outcome measures (PROMs) are standardized, validated questionnaires completed by patients to measure their perception of their well-being and health status. Aim: To create a cost-effective, valid, and sensitive PROMs data capture process for patients with Advanced Heart Failure (AHF) to understand to what extent a Heart Transplant (HT) affects their quality of life Methods A prospective data collection model has been designed for AHF patients eligible for HT based on the Outcomes Management and Evaluation (OME) system developed by Cleveland Clinic. Two types of data will be collected: 1) Patient condition-specific PROMs; 2) OME for HT and potential Bridge to Transplant Therapies (BTT). Patient condition-specific PROMs will be measured using the Kansas City Cardiomyopathy Questionnaire and social determinants of health (e.g., smoking habits and drug abuse). The OME data for BTT include: A)Pre-BTT details (e.g., UNOS status),B)Post-BTT details (e.g., post-transplant mechanical support). The OME data for HT include:A)Pre-transplant details (e.g., UNOS status),B)Donor characteristics (e.g., ischemic trigger greater than 4 hours),C)Post-transplant details (e.g., post-transplant mechanical support). The process for collecting PROMs is divided into 5 phases (see fig). Results Data will start to be collected approximately in November 2020 until June 2021, aiming to have the first results analyzed by July 2021 Conclusion This is one of the first PROMs processes implemented in an AHF program to the best of our knowledge. Our goal is to imbed PROMs into our workflow and create an umbrella of PROMs across the entire Heart and Vascular Institute to measure the quality of care from our patients’ perspective to improve the clinical decision-making process. more...

As transcatheter aortic valve replacement (TAVR) has become routine, device manufacturers and investigational cardiologists have set their sights on the mitral valve. Although transcatheter mitral valve replacement (TMVR) poses several technical challenges, they appear to be surmountable, and work is proceeding. Here we review the various devices being developed and preliminary results of trials in humans. more...

A 75-year-old man presented with dyspnea requiring home oxygen, on a background of partial colectomy for colon cancer, chronic renal failure, and coronary artery bypass graft surgery in 1978 (left internal mammary artery to left anterior descending graft and saphenous vein grafts [SVG] to the right coronary artery [RCA] and left circumflex artery). Clinically, he had jugular venous distension and bibasal crepitations, without overt ascites or peripheral edema. Chest x-ray demonstrated remote postoperative changes, cardiomegaly, mild pericardial calcification, and other radiographic findings of congestive heart failure, without apparent mediastinal mass (Figure 1). However, echocardiography revealed a large (9.4×8.7 cm), apparently extracardiac, mass compressing the right ventricle with severe functional tricuspid stenosis (mean gradient, 10 mm Hg) and turbulence of forward transtricuspid flow on color Doppler imaging (Figures 2A, 2B, and 3; Movie IA and IB in the online-only Data Supplement). Noncontrast cardiac MRI revealed a large (10.9×7.4×6.5 cm), relatively homogenous structure adjacent to the atrioventricular groove anteriorly, which was compressing the right heart and obstructing the tricuspid valve. The mass was distinct from adipose tissue, well circumscribed by overlying pericardium, and had no invasive characteristics. Cine imaging demonstrated flow within the mass. The structure location and characteristics were consistent with a partially thrombosed SVG aneurysm (Figure 4; Movie II … more...

AIM Transcatheter mitral valve implantation (TMVI) is a novel technology for patients with severe mitral valve disease but at high surgical risk. Imaging guidance during the procedure is critical for successful device deployment. Identification of the mitral annular plane (MAP) with fluoroscopy during the procedure is limited by lack of clearly defined landmarks. We hypothesized that a plane defined by left circumflex-right coronary arteries (LCX-RCA) would have a consistent relationship to MAP. METHODS AND RESULTS We studied 25 patients with gated cardiac computed tomography. We identified the MAP and the LCX-RCA plane in mid systole and diastole. The distance between the two planes in prespecified four points (anterior, posterior, medial, and lateral) in the apical 2 and 3-chamber views. Alignment of the planes was described by cranial/caudal angulation for both planes in RAO 30° and LAO 90° (lateral) angulation. Mean age was 81 ± 9 years, 56% of patients had ≥2+ mitral regurgitation. In mid systole, the distances between the LCX-RCA plane and the MAP in the four points were more...

Introduction Cardiac allograft vasculopathy (CAV) is known as the primary cause of death in the first year after orthotopic heart transplant (OHT). Coronary artery spasm (CAS) in OHT is a rare and under-recognized phenomenon in patients undergoing surveillance. The mechanism of coronary vasospasm in OHT remain largely unknown. The presentation can vary from an incidental finding to severe episodes of symptomatic ventricular arrhythmias, high-degree atrioventricular block, syncope, cardiac arrest, or even myocardial infarction in cases of prolonged ischemia. Case Presentation 65 yo female with history of chronic kidney disease, diabetes mellitus type 2, hypertension, hyperlipidemia, and orthotopic heart transplantation with CMV mismatch in 2016 secondary to apical hypertrophic cardiomyopathy. Prior coronary angiography (CA) done at our institution had shown no evidence of vasculopathy. During one of her follow-up visits in the Clinic, she complained of increasing dyspnea on exertion, prompting urgent referral for CA, as per our surveillance protocols. Prior to the procedure, echocardiography was performed which revealed normal graft function and no valvular abnormalities. She underwent CA which showed a proximal significant diffuse luminal narrowing of the right coronary artery (RCA) (Image 1) and normal left coronary artery anatomy (Image 2). We proceed to repeat CA with intracoronary administration of nitroglycerin (ICN) and measurement of fractional flow reserve (FFR) of RCA (Image 3, 4). Angiography revealed near resolution of the RCA lesion, ultimately suggesting that transient vasospasm had been responsible for the previous angiographic appearance (Image 1). Summary CAS can present in patients with or without vasculopathy. It can produce luminal narrowing and can be difficult to distinguish angiographically from CAV. Misdiagnosis of this entity has led to the incorrect diagnosis of CAV and subsequent unnecessary stenting. ICN use can improve angiographic visualization, and prevent the adverse effects of coronary spasm. In conclusion, CAS is a rare and potential complication post OHT. It is a difficult entity to prognosticate due to scarcity of clinical evidence, as prevalence ranges from 4.9% to 12.1%. Some authors hypothesize that CAS in OHT carries a poor prognosis as it is often an early manifestation of CAV. However, this remains largely hypothetical and further studies are needed to better understand this disease. more...

IMPORTANCE: Infective endocarditis is a life-threating condition with annual mortality of as much as 40% and is associated with embolic events in as many as 80% of cases. These embolic events have notable prognostic implications and have been linked to increased length of stay in intensive care units and mortality. A vegetation size greater than 10 mm has often been suggested as an optimal cutoff to estimate the risk of embolism, but the evidence is based largely on small observational studies. OBJECTIVE: To study the association of vegetation size greater than 10 mm with embolic events using meta-analytic techniques. DATA SOURCES: A computerized literature search of all publications in the PubMed and EMBASE databases from inception to May 1, 2017, was performed with search terms including varying combinations of infective endocarditis, emboli, vegetation size, pulmonary infarct, stroke, splenic emboli, renal emboli, retinal emboli, and mesenteric emboli. This search was last assessed as being up to date on May 1, 2017. STUDY SELECTION: Observational studies or randomized clinical trials that evaluated the association of vegetation size greater than 10 mm with embolic events in adult patients with infective endocarditis were included. Conference abstracts and non–English language literature were excluded. The search was conducted by 2 independent reviewers blinded to the other’s work. DATA EXTRACTION AND SYNTHESIS: Following PRISMA guidelines, the 2 reviewers independently extracted data; disputes were resolved with consensus or by a third investigator. Categorical dichotomous data were summarized across treatment arms using Mantel-Haenszel odds ratios (ORs) with 95% CIs. Heterogeneity of effects was evaluated using the Higgins I(2) statistic. RESULTS: The search yielded 21 unique studies published from 1983 to 2016 with a total of 6646 unique patients with infective endocarditis and 5116 vegetations with available dimensions. Patients with a vegetation size greater than 10 mm had increased odds of embolic events (OR, 2.28; 95% CI, 1.71-3.05; P more...

Background Reconstruction of the intervalvular fibrosa (IVF) for invasive double-valve infective endocarditis (IE) is a technically challenging operation. This study presents the long-term outcomes of two surgical techniques for IVF reconstruction. Methods From 1988 to 2017, 138 patients with invasive double-valve IE underwent surgical reconstruction of the IVF, along with double-valve replacement (Commando procedure, n = 86) or aortic valve replacement with mitral valve repair (hemi-Commando procedure, n = 52). Mean follow-up was 41 ± 5.9 months. Results Reoperation was required in 82% of patients, and 34% underwent emergency surgery. Pathologic features included positive blood cultures (90%), prosthetic valve IE (75%), aortic root abscess (78%), mitral annular abscess (24%), and intracardiac fistula (12%). There were 28 hospital deaths: 21 (24%) in the Commando group and 7 (14%) in the hemi-Commando group (P = .12). Overall survival at 1, 5, and 10 years was 67%, 48%, and 37%, respectively. Coronary artery disease, native valve IE, and causative organism (Staphylococcus aureus, coagulase-negative Staphylococcus, and viridans streptococci) were risk factors for late mortality. Freedom from reoperation at 1, 5, and 8 years was 87%, 74%, and 55%, respectively. Freedom from recurrent IE at 1, 5, and 8 years was 90%, 78%, and 67%, respectively. Conclusions Although it is technically demanding, surgery for invasive IE involving IVF, which provides the only chance for cure, can be performed with reasonable clinical outcomes. In cases of IE invading the IVF and limited to the anterior mitral valve leaflet, a hemi-Commando procedure that includes mitral valve repair has improved early outcomes. more...

Paravalvular aortic regurgitation (AR) after transcatheter aortic valve replacement (TAVR) is a well-known complication. Post-TAVR AR is thought to be caused by incomplete apposition of the prosthesis, suboptimal expansion of the stent frame, misplacement of the prosthesis, or mismatch in the size more...

We would like to thank Dr. Felix-Oliveira and colleagues for bringing up a very important alternative for contralateral access. The idea of using the radial artery as an alternative access site for crossover is appealing, and the initial data from a small number of patients (N = 46) showed no more...

Damage to the cardiac conduction system requiring permanent pacemaker implantation is a complication of aortic valve replacement (AVR) that may importantly affect quality of life. We investigated the prevalence of and preprocedure risk factors for new permanent pacemakers after surgical (SAVR) and transcatheter AVR (TAVR) at a single institution.Preoperative variables and baseline electrocardiograms were reviewed for 5807 patients undergoing elective SAVR, with or without coronary artery bypass grafting, and 1292 undergoing TAVR, with or without percutaneous coronary intervention, from 2006 to 2017 at Cleveland Clinic. Patients with previous permanent pacemakers were excluded. Risk factors for permanent pacemaker implantation were identified using multivariable logistic regression analysis.New permanent pacemakers were implanted in 151 (2.6%) after SAVR and in 125 (9.7%) after TAVR (whole group SAVR vs TAVR, P.0001). Risk factors for pacemaker implantation after TAVR included preoperative conduction disturbances and type of prosthesis (SAPIEN, 9.5%; SAPIEN XT, 4.8%; SAPIEN 3, 10% [Edwards Lifesciences, Irvine, CA]; CoreValve, 30% [Medtronic, Minneapolis, MN]; and other TAVR, 10%). There were no reliable risk factors for pacemaker implantation after SAVR. Bicuspid valves, mechanical vs bioprosthetic valves, higher Society of Thoracic Surgeons risk score, and concomitant coronary artery bypass grafting were not associated with elevated risk.At a high-volume institution in the current era, establishing a baseline for pacemaker implantation after AVR is necessary. Preoperative conduction disturbances and transcatheter valve type affect its prevalence. These data provide a benchmark that should be taken into account when considering TAVR in low-risk patients. more...

Despite the growing evidence with emerging transcatheter tricuspid valve repair therapies, the experience with transcatheter tricuspid valve replacement remains sparse. We describe a case of severe tricuspid regurgitation in a 79-year-old patient deemed unsuitable for isolated tricuspid valve surgery, successfully treated with a 40-mm self-expandable NaviGate (NaviGate Cardiac Structures, Inc, Lake Forest, CA) valved stent via a transatrial approach, with excellent result and hemodynamic performance at 4 months. more...

Objectives Consensus regarding initial cannulation site for acute type A dissection repair is lacking. Objectives were to review our experience with systematic initial axillary artery cannulation, characterize patients on the basis of cannulation site, and assess outcomes. Methods From January 2000 to January 2017, 775 patients underwent emergency acute type A dissection repair. Initial axillary cannulation was performed in 617 (80%), femoral in 93 (12%), and central in 65 (8.4%). In-hospital mortality and stroke risk factors were identified using logistic regression. Results Reasons for selecting initial central or femoral instead of axillary cannulation included unsuitable axillary anatomy (n = 67; 42%), surgeon preference (n = 38; 24%), hemodynamic instability (n = 34; 22%), and preexisting cannulation (n = 19; 12%). Cannulation site was shifted or added intraoperatively in 82 (11%), with initial cannulation site being axillary (n = 23 of 617; 3.7%), central (6 of 65; 9.2%), or femoral (n = 53 of 93; 57%), for surgeon preference (n = 60; 73%), high flow resistance (n = 13; 16%), increased aortic false lumen flow (n = 6; 7.3%), and other (n = 3; 3.7%). In-hospital mortality was 8.6% (n = 67; lowest for axillary, 7.3% [P = .02]) and stroke 8.3% (n = 64). Hemodynamic instability (odds ratio [OR], 7.6; 95% confidence interval [CI], 4.2-14), limb ischemia (OR, 3.7; 95% CI, 1.5-9.3), stroke (OR, 5.5; 95% CI, 2.2-14), and aortic regurgitation (OR, 2.2; 95% CI, 1.2-4.2) at presentation were risk factors for mortality and central cannulation site (OR, 2.3; 95% CI, 1.05-5.1) and aortic stenosis (OR, 2.4; 95% CI, 1.2-4.6) for stroke. Conclusions Systematic initial axillary cannulation for acute type A dissection repair is safe and effective and can be tailored to patients' specific needs. With this strategy, comparable outcomes are observed among cannulation sites and are largely determined according to patient presentation rather than cannulation site. more...

Objective The objective of this study was to compare safety and clinical effectiveness of negative-pressure wound therapy (NPWT) with traditional wound therapy for managing noninfected open chests with delayed sternal closure after cardiac surgery. Methods From January 2000 to July 2015, 452 of 47,325 patients who underwent full sternotomy left the operating room with a noninfected open chest (0.96%), managed using NPWT in 214—with frequency of use rapidly increasing to near 100%—and traditionally in 238. Predominant indications for open-chest management were uncontrolled coagulopathy or hemodynamic compromise on attempted chest closure. Weighted propensity-score matching was used to assess in-hospital complications and time-related survival. Results NPWT and traditionally managed patients had similar high-risk preoperative profiles. Most underwent reoperations (63% of the NPWT group and 57% of the traditional group), and 21% versus 25% were emergency procedures. Reexplorations for bleeding were less common with NPWT versus traditional wound therapy (n = 63 [29%] vs 104 [44%], P = .002). Median duration of open-chest to definitive sternal closure was 3.5 days for NPWT versus 3.1 for traditionally managed patients (P[log rank] = .07). Seven patients (3.3%) were converted from NPWT to traditional therapy because of hemodynamic intolerance and 6 (2.5%) from traditional to NPWT. No NPWT-related cardiovascular injuries occurred. Among matched patients, NPWT was associated with better early survival (61% vs 44% at 6 months; P = .02). Conclusions NPWT is safe and effective for managing noninfected open chests after cardiac surgery. By facilitating open-chest management and potentially improving outcomes, it has become our therapy of choice and perhaps has lowered our threshold for leaving the chest open after cardiac surgery. more...

We report a 62-year-old male who had severe aortic insufficiency after a homograft root replacement, requiring venoarterial extracorporeal membrane oxygenation prior to surgery due to profound cardiogenic shock. Severe aortic insufficiency is a contraindication for venoarterial extracorporeal membrane oxygenation, but we were able to stabilize the patient and successfully perform an urgent reoperative surgery. more...

Background Data regarding the risk of aortic dissection in patients with bicuspid aortic valve and large ascending aortic diameter are limited, and appropriate timing of prophylactic ascending aortic replacement lacks consensus. Thus our objectives were to determine the risk of aortic dissection based on initial cross-sectional imaging data and clinical variables and to isolate predictors of aortic intervention in those initially prescribed serial surveillance imaging. Methods From January 1995 to January 2014, 1,181 patients with bicuspid aortic valve underwent cross-sectional computed tomography (CT) or magnetic resonance imaging (MRI) to ascertain sinus or tubular ascending aortic diameter greater than or equal to 4.7 cm. Random Forest classification was used to identify risk factors for aortic dissection, and among patients undergoing surveillance, time-related analysis was used to identify risk factors for aortic intervention. Results Prevalence of type A dissection that was detected by imaging or was found at operation or on follow-up was 5.3% (n = 63). Probability of type A dissection increased gradually at a sinus diameter of 5.0 cm—from 4.1% to 13% at 7.2 cm—and then increased steeply at an ascending aortic diameter of 5.3 cm—from 3.8% to 35% at 8.4 cm—corresponding to a cross-sectional area to height ratio of 10 cm 2 /m for sinuses of Valsalva and 13 cm 2 /m for the tubular ascending aorta. Cross-sectional area to height ratio was the best predictor of type A dissection (area under the curve [AUC] = 0.73). Conclusions Early prophylactic ascending aortic replacement in patients with bicuspid aortic valve should be considered at high-volume aortic centers to reduce the high risk of preventable type A dissection in those with aortas larger than approximately 5.0 cm or with a cross-sectional area to height ratio greater than approximately 10 cm 2 /m. more...

Infective endocarditis is a major cause of morbidity and mortality among individuals with opioid use disorder who use injection drugs. It is frequently associated with tricuspid valve endocarditis and Staphylococcus aureus bacteremia, with secondary pulmonary septic emboli. Herein, we report a unique case of pulmonary cavitation injury following pulmonary septic emboli in the setting of tricuspid valve endocarditis in an injection drug user with opioid use disorder. The pattern of cavitary lung injury mimics radiographically indistinguishable features from vanishing lung syndrome during the most advanced stage of her illness. . more...

Background Paravalvular leak (PVL) is often seen after aortic (AV) and mitral valve (MV) surgery, either due to infection or valve dehiscence. We sought to describe predictors of longer-term outcomes in patients who developed PVL after AV and MV surgery and were considered eligible for reoperative cardiac surgery (RCS). Methods We studied 495 such patients (65 ± 14 years, 65% men, 47% with MV PVL) who presented at our center between January 2003 and December 2011. Patients with severe mitral/aortic stenosis, patients with less than mild PVL, and those with prohibitive risk precluding RCS were excluded. Society of Thoracic Surgeons (STS) score was calculated. Primary endpoint was mortality. Results At baseline, mean STS score and left ventricular ejection fraction were 5.8 ± 4% and 52 ± 12%, respectively. In total, 105 (21%) had infective PVL and 72% had moderate or greater PVL. At a median of 8 days, 351 (71%) patients underwent RCS to repair PVL (3% in-hospital postoperative mortality), and at 6.6 ± 4 years, 230 (47%) patients died. On multivariable Cox survival analysis, greater STS score (hazard ratio or HR 1.35), mitral versus aortic PVL (HR 1.66), infectious etiology (HR 2.05), and greater right ventricular systolic pressure (HR 1.09) were associated with greater longer-term mortality, whereas surgery (HR 0.58) was associated with improved longer-term survival (all P Conclusions Patients who develop mild or greater PVL after AV/MV surgery have a high rate of longer-term mortality, despite excellent perioperative outcomes. Greater STS score, right ventricular systolic pressure, infectious etiology, and MV (vs AV) involvement were all independently associated with long-term mortality, whereas RCS for PVL closure was associated with improved longer-term survival. more...

Visual Abstract, Highlights • Surgery for isolated tricuspid regurgitation carries a high mortality risk, especially in the setting of right ventricular dysfunction and reoperation. • Transcatheter valve therapy is as promising alternative for treatment of isolated tricuspid valve disease associated with right heart failure. • The NaviGate bioprosthesis is a novel self-expanding valved stent designed to treat functional tricuspid regurgitation. • The preclinical evaluation shows that transcatheter tricuspid valve implantation using the NaviGate device is safe, is feasible through 2 different approaches, and results in a secure and stable engagement of the native annulus, with excellent hemodynamic and valve performance., Summary Patients with isolated functional or recurrent tricuspid regurgitation are often denied surgery because they are considered to be at high risk. Transcatheter valve therapy provides a less invasive alternative for tricuspid regurgitation associated with right heart failure. We have evaluated the feasibility of transcatheter tricuspid valve implantation of the NaviGate valved stent in a long-term swine model. The valved stent was successfully implanted through transjugular and transatrial approaches on the beating heart with excellent hemodynamic and valve performance. No conduction disturbance or coronary obstruction was observed. This technology could provide an alternative treatment for patients who are at high surgical risk with severe tricuspid regurgitation and compromised right ventricular function. more...