High Risk For Open Heart Surgery Research Articles

Successful management of the leaflet perforation after the transcatheter edge-to-edge repair procedure using transcatheter occlusion.

A 57-year-old female was diagnosed with chronic heart failure and severe functional mitral regurgitation (FMR) despite guideline-directed medical therapy. An echocardiogram revealed severe mitral regurgitation (MR) (4+) vena contracta width 8 mm with ejection fraction (21%), and no calcification on the annulus and leaflets was noted. Mitral transcatheter edge-to-edge repair (TEER) was attempted for this patient. Transcatheter edge-to-edge repair was done under general anaesthesia with transoesophageal echocardiography (TEE) guidance using a novel designed SQ-Krin TEER system (Shenqi Medical). After transseptal puncture was achieved, a 24F guiding sheath was placed in the left atrium (LA). Then, one LW-size clip (6 mm width with 12 mm arm length) was placed in the A2/P2 region (Panel A). Mitral regurgitation severity was reduced to none (Panel A). However, 20 min after release, TEE revealed a large regurgitant gap (7–8 mm) between the anterior mitral leaflet (AML) and the clip arm with torrential MR (Panels B–D), and clip-induced leaflet perforation was confirmed. Considering the high risk of open-heart surgery, transcatheter occlusion was attempted. A 14F steerable catheter was placed in the LA through the previous puncture site, and the guide wire was placed into the left ventricle (LV) through the tear hole, and then a 14 mm Amplatzer Vascular Plug II (St Jude Medical, Abbott) was implanted through the delivery system to occlude the hole (Panels E and F). Mitral regurgitation was reduced to a mild degree after the procedure (Panels G and H). Post-operative recovery was uneventful and no sign of haemolysis. In the 1-year follow-up, the patient presented good condition with mild MR, and both the clip and the plug were in a stable position (Panel I). Leaflet perforation after the TEER procedure is a rare complication with a poor prognosis, especially for an FMR patient. Other than open-heart surgery, transcatheter occlusion may provide a reliable salvage management option.

Transjugular Transcatheter Tricuspid Valve Implantation of LuX-Valve Bioprosthesis in a Preclinical Model.

The purpose of this preclinical study in a sheep model was to confirm the feasibility and safety of the LuX-Valve transjugular tricuspid valve (TV) replacement apparatus and to optimize the implantation procedure before beginning first-in-man study. The LuX-Valve was implanted in a sheep model (n = 8) via transjugular approach. Six of eight sheep underwent successful implantation procedure on beating heart. The first two sheep died during the prostheses deployment. In the remaining 6 sheep that survived, postoperative echocardiography results showed there was no paravalvular leakage (PVL) and central tricuspid regurgitation in 5 animals, whereas 1 animal had mild PVL. The mean transvalvular gradient was 1.1 ± 0.9mm Hg at the 4-week follow-up. No right ventricular outflow tract (RVOT) obstruction, device malposition, pericardial effusion, coronary artery compression, or arrhythmias were observed. This technology may be a promising alternative for TR patients who are at high risk for open-heart surgery. Transjugular tricuspid valved-stent implantation. a Transjugular tricuspid valve replacement in a sheep model. b and c Valved stent. d, e, and f Schematic depiction of the implantation procedure.

Role of computed tomography in transcatheter replacement of ‘other valves’: a comprehensive review of preprocedural imaging

Transcatheter procedures for heart valve repair or replacement represent a valid alternative for treating patients who are inoperable or at a high risk for open-heart surgery. The transcatheter approach has become predominant over surgical intervention for aortic valve disease, but it is also increasingly utilized for diseases of the 'other valves', that is the mitral and, to a lesser extent, tricuspid and pulmonary valve. Preprocedural imaging is essential for planning the transcatheter intervention and computed tomography has become the main imaging modality by providing information that can guide the type of treatment and choice of device as well as predict outcome and prevent complications. In particular, preprocedural computed tomography is useful for providing anatomic details and simulating the effects of device implantation using 3D models. Transcatheter mitral valve replacement is indicated for the treatment of mitral regurgitation, either primary or secondary, and computed tomography is crucial for the success of the procedure. It allows evaluating the mitral valve apparatus, the surrounding structures and the left heart chambers, identifying the best access route and the landing zone and myocardial shelf, and predicting obstruction of the left ventricular outflow tract, which is the most frequent postprocedural complication. Tricuspid valve regurgitation with or without stenosis and pulmonary valve stenosis and regurgitation can also be treated using a transcatheter approach. Computer tomography provides information on the tricuspid and pulmonary valve apparatus, the structures that are spatially related to it and may be affected by the procedure, the right heart chambers and the right ventricular outflow tract.

Risk Stratification of Percutaneous Edge-to-Edge Repair by MitraClip in Patients with Mitral Regurgitation.

Edge-to-edge repair using the MitraClip system is indicated in patients with severe mitral regurgitation (MR) who are at high risk for open-heart surgery due to comorbidity or reduced cardiac function. However, less is known about pre-procedural risk factors for mortality and morbidity following MitraClip implantation. Consecutive 25 patients with severe MR who underwent MitraClip therapy (mean age, 77 years old, 14 males) were included. Right heart catheterization and echocardiographic data before and after the procedure were collected and their prognostic impacts were investigated. Acute procedural success was 96%. At one week following MitraClip repair, left ventricular ejection fraction (LVEF) remained unchanged and left ventricular end-diastolic volume tended to be smaller. Cardiac index and mean pulmonary artery pressure (mPAP) were markedly improved following the procedure (P < 0.001 for both). In the multivariate analyses using baseline characteristics, both lower LVEF (hazard ratio 0.57, 95% confidence interval 0.30-0.89) and higher mPAP (hazard ratio 1.23, 95% confidence interval 1.06-1.56) were independently associated with post-procedural 1-year death or heart failure readmission (P < 0.05 for both). The lower LVEF and higher mPAP group had lower 1-year survival free from HF readmission compared with those without (16.7% versus 100%; P < 0.001). In conclusion, a combination of baseline mPAP and LVEF might be a useful tool in predicting post-MitraClip procedural clinical outcomes.

Long-term outcomes of myocardial and cerebral revascularization with combined or staged percutaneous interventions and carotid endarterectomy

Aim To evaluate in-hospital and long-term outcomes of myocardial and cerebral revascularization with combined or staged PCI and carotid endarterectomy.Methods.263 myocardial and cerebral revascularizations with PCI and CEA in patients with combined cerebral and coronary artery lesions in the period from 2011 to 2017 were performed. Patients were divided into two groups depending on the surgical strategy. Patient (n = 133) who underwent a staged intervention (CEA and PCI) were included in Group 1, whereas patients (n = 130) who underwent a hybrid intervention (CEE+PCI CA) were included in Group 2. The mean follow-up was 3.5 years.Results.100% of patients in Group 2 underwent coronary and internal carotid revascularization according to the results of in-hospital and long-term follow-up. 81.35% of patient in Group 1 underwent PCI and CEA, whereas 3.01% of patients underwent only PCI and 6.77% of patients – CEA. 1.5% of patients in Group 1 did not receive any surgical treatment. The most common causes of incomplete revascularization were the subsequent change of the initially defined treatment for myocardial (6.02%) or cerebral revascularization (0.75%). The rest refused the second stage, or it was associated with extremely high risk and the strategy was switched to the conservative therapy.Conclusion.100% of patients received hybrid myocardial and cerebral revascularization during one hospitalization. It allowed reducing mortality from MI and stroke during the waiting period for the next stage of the treatment in Group 1 (almost 5%). Hybrid interventions can be used in patients with high risk for open-heart surgery, severe comorbidities (obesity, diabetes, renal dysfunction), significant coronary and cerebral artery lesions with high risk of MI and stroke. However, hybrid approach was associated with high rate (almost 7%) of non-fatal MI in the long-term follow-up.

Galectin-3 and ST2 as predictors of therapeutic success in high-risk patients undergoing percutaneous mitral valve repair (MitraClip).

Percutaneous mitral valve repair (PMVR) is an interventional treatment option in patients with severe mitral regurgitation (MR) and at high risk for open-heart surgery. Currently, limited information exists about predictors of procedural success after PMVR. Galectin-3 (Gal-3) and suppression of tumorigenicity 2 (ST2) induce fibrotic alterations in severe MR and heart failure. We sought to examine the predictive value of Gal-3 and ST2 as specific indicators of therapeutic success in high-risk patients undergoing PMVR. We hypothesize that extended cardiac fibrotic alterations might have impact on successful MR reduction after the MitraClip procedure. A total of 210 consecutive patients undergoing PMVR using the MitraClip system were included in this study. Procedural success was defined as an immediate reduction of MR by ≥2 grades, assessed by echocardiography. Venous blood samples were collected prior to PMVR and at 6 months follow-up for biomarker analysis. After PMVR there was a significant reduction in the severity of MR (MR grade: 3 ±0.3 vs 1.6 ±0.6, P <0.001). Low baseline Gal-3 levels (PMVRsuccess : 22.0 ng/mL [IQR, 17.3-30.9] vs PMVRfailure : 30.6 ng/mL [IQR, 24.8-42.3], P <0.001) and ST2 levels (PMVRsuccess : 900.0 pg/mL [IQR, 619.5-1114.5] vs PMVRfailure : 1728.0 pg/mL [IQR, 1051.March 1, 1930], P < 0.001) were associated with successful MR reduction after PMVR. Also, ROC analysis identified low baseline Gal-3 and ST2 levels as predictors of therapeutic success after PMVR (AUCGal-3 :0.721 [IQR, 0.64-0.803], P < 0.001; AUCST2 : 0.807 [IQR, 0.741-0.872], P < 0.001). There was an association between low Gal-3 and ST2 plasma levels and successful MR reduction in patients with severe MR undergoing PMVR using the MitraClip system.

Treatment of high-risk patients with severe aortic stenosis by the use of transcatheter aortic valve implantation

Aortic stenosis is the most common disease from the group of acquired heart diseases. The frequency and degree of damage of the aortic valve increases with age. The prevalence of this disease increases due to the general extension in life expectancy of the population. Aortic valve stenosis caused by calcification is the pathology with progressive course characterized by a poor prognosis at the stage of expanded symptoms. Five-year survival of patients with developed clinical picture of aortic stenosis without surgery, according to some estimates, is reduced to 15%, which is the worst figure, even in comparison with most potentially incurable cancer. In the treatment of aortic stenosis aortic valve replacement is the “gold standard” and gives positive results in all age groups of patients. Only one third of patients are sent for aortic valve replacement owing to high risk caused by the age, severity of the defect, reduced contractility of the left ventricle, pulmonary hypertension and other comorbidities. Aortic valve replacement in patients of the older age groups with concomitant diseases is associated with high level of hospital mortality. One of the attempts to reduce the frequency of complications and mortality in this group of patients is the implementation of a less traumatic surgery – transcatheter aortic valve implantation. At present our clinic has successfully performed more than 70 operations of transcatheter aortic valve implantation. Transcatheter aortic valve implantation is a good alternative to standard aortic valve replacement in patients with high risk of open-heart surgery.

Transapical transcatheter aortic valve implantation using a new second-generation TAVI system — J-Valve™ for high-risk patients with aortic valve diseases: Initial results with 90-day follow-up

BackgroundTo evaluate the safety and efficacy of transcatheter aortic valve implantation (TAVI) for patients with aortic stenosis (AS) or pure/dominant aortic regurgitation (AR) using the J-Valve™ system. MethodsTwenty patients with isolated aortic valve disease (11 with pure/dominant AR and 9 with AS) at high risk for open-heart surgery were enrolled in this study. The mean Logistic Euro-SCORE I was 27.2±8.2% (mean age 74.5±4.7years). Four sizes of prosthesis were used for annular size up to 21 mm (n=1), 23mm (n=2), 25mm (n=10) and 27mm (n=7). Clinical and echocardiographic evaluations were performed at baseline, post-procedure and follow-up. The primary endpoint was all-cause mortality. Secondary endpoints were procedural success, major adverse events as well as echocardiographic performance. ResultsTAVI with the J-Valve™ device was successfully performed in 19 patients (95%). Conversion to surgical valve replacement was necessary in one patient due to prosthesis embolization. No mortality occurred during 90 days follow-up. Pacemaker implantation for new onset conduction disorders was necessary in one patient (5%). For patient with severe AS, post-procedure TAVI resulted in favorable reduction of mean transvalvular gradients (55.3±8.5 vs. 16.4±13.3 mmHg, P<0.01). Mean transvalvular gradient was also favorable in AR patients after valve implantation (6.9±1mmHg). The majority of patients had none or trivial paravalvular regurgitation (17/19) while none had moderate or severe paravalvular regurgitation. ConclusionTrans-apical TAVI using the J-Valve™ prosthesis is potentially an effective treatment option for patients with AS or pure/dominant AR at high risk for open-heart surgery.

Introduction of an interdisciplinary heart team-based transcatheter aortic valve implantation programme: short and mid-term outcomes.

Transcatheter aortic valve implantation (TAVI) has been developed to treat symptomatic aortic stenosis in patients deemed too high risk for open-heart surgery. To address this complex population, an interdisciplinary heart team approach was proposed. Present the short- and mid-term outcomes of the first 100 patients in the Royal Prince Alfred Hospital multidisciplinary TAVI programme. Single-centre registry. Baseline and procedural data were prospectively recorded. Outcomes were recorded according to Valve Academic Research Consortium - version 2 guidelines. All patients underwent a comprehensive interdisciplinary pre-procedural evaluation. Sixty-eight transfemoral and 32 transapical implantations were performed. Mean age was 82 (±8.9) years old with an average logistic EuroSCORE of 33. Although 13 procedures had major complications, there was no intraprocedural mortality. During the first month, 9% of patients were re-admitted due to heart failure and 13% had a permanent pacemaker implanted. A 3% 30-day and 8% follow-up (mean 17 months) mortalities were recorded. While no significant differences in the rate of complications were found between the first and second half of the experience, all cases of mortality within 30 days (n = 3) occurred in the initial half. Sustained haemodynamic results were obtained with TAVI (immediate mean aortic valve gradient reduction from 47 to 9 mmHg; 1-year echocardiographic gradient 9.9 mmHg, with no moderate or severe aortic regurgitation). Excellent results can be achieved with TAVI in very high-risk patients at an Australian institution. A comprehensive evaluation based on a heart team can overcome most of the difficulties imposed by this challenging population.

Why not "Simplify" TAVI?

, FACC, FSCA Aortic stenosis among the elderly is associated with a substantial increase in morbidity and mortality once symptoms such as angina, syncope, or heart failure develop. Since 2002, transcatheter aortic valve implantation (TAVI) has been established as an emerging therapeutic approach for patients with unacceptable surgical risk and a less invasive alternate treatment option for patients at high risk for openheart surgery. Meanwhile, more than 60,000 patients underwent TAVI procedures worldwide and the dramatic growth in TAVI will possibly continue over the next years. New technology advances promise to simplify TAVI and to improve outcome by reducing the rate of TAVI-specific issues such as stroke, paravalvular aortic regurgitation, acute kidney injury, vascular complications, and conduction disturbances. Mendiz and co-workers report about their initial

Risk prediction and outcomes in patients with liver cirrhosis undergoing open-heart surgery☆

There are few data assessing factors, which identify patients with liver cirrhosis (LC) facing high risk for open-heart surgery. We sought to compare the Model for End-Stage Liver Disease (MELD) score, the Child-Turcotte-Pugh (CTP) classification and the European system for cardiac operative risk evaluation (EuroSCORE) for risk prediction in cirrhotic patients. Fifty-seven consecutive patients with non-cardiac LC, who underwent open-heart surgery with the use of cardiopulmonary bypass between 1998 and 2008, were studied at our institution. Potential preoperative predictors of outcome, as well as preoperative MELD score, CTP classification and EuroSCORE were calculated. The primary study end points were all-cause in-hospital and long-term mortality. MELD score and CTP classification both differed significantly between survivors and non-survivors for in-hospital (P<0.0001) and long-term mortality (P<0.0001). Univariate predictors of in-hospital mortality were emergency surgery (odds ratio (OR), 4.9; 95% confidence interval (CI), 1.2-20.6; P=0.03), ascites (OR, 7.2; 95% CI, 2.0-25.5; P=0.002), total serum protein (OR, 0.4; 95% CI, 0.2-0.8; P=0.01), CTP class (OR, 5.5; 95% CI, 1.4-21.5; P=0.04) and MELD score (OR, 1.4; 95% CI, 1.1-1.6; P=0.001). Multivariable exact logistic regression analyses revealed MELD score (OR, 1.3; 95% CI, 1.005-1.6; P=0.04) as the only independent factor associated with in-hospital mortality. Receiver operating characteristic curve (ROC) analysis showed MELD score to be highly predictive with an optimal cut-off value of 13.5 (sensitivity: 82.0%, specificity: 78.5%) for postoperative in-hospital mortality (area under curve (AUC): 85.1 ± 0.05%) and superior compared to the CTP classification (AUC: 75.7±0.08%) and EuroSCORE (AUC: 65.9 ± 0.08%). The mortality of patients with liver cirrhosis undergoing open-heart surgery progressively increases with the severity of liver dysfunction. Therefore, the MELD score most reliably identifies those cirrhotic patients who are at high risk for open-heart surgery.

Interventional Cardiology Perspective of Functional Tricuspid Regurgitation

A vast unmet need exists for tricuspid valve (TV) repair for functional tricuspid regurgitation (FTR) among patients undergoing left heart valve surgery. The FTR is a dynamic entity that is governed by several pathophysiologic mechanisms like TV annular dilatation, annular shape, pulmonary hypertension, left or right ventricle dysfunction, right ventricle geometry, and leaflet tethering. Treatment options for FTR are primarily surgical. No clear medical management exists for treatment of FTR. Several studies have demonstrated improvement in functional status along with tricuspid regurgitation grades among individuals undergoing concomitant TV repair as compared with those undergoing only left heart valve surgery, although data on mortality benefits are equivocal. Percutaneous TV technology may be initially useful for patients with FTR who are at high risk for open-heart surgery. Once the other percutaneous technologies for mitral, aortic, or pulmonary valve become widely available, the need for percutaneous TV procedures will be even more apparent. Initial data from animal studies have shown encouraging results. A concurrent effort is being invested to develop effective mechanistic models, right stent materials, superior valve devices along with a precise technology for valve deployment. The current prevalence of moderate-to-severe tricuspid regurgitation (TR) is estimated to be 1.6 million in the United States.1 Of these, only ≈8000 patients undergo tricuspid valve (TV) surgeries annually, most of them in conjunction with left heart valve surgeries (LHVSs).1 This has resulted in a vast unmet need of recognizing and effectively treating TR in adult populations. With the decline of rheumatic heart disease, a large proportion of the TR encountered is functional rather than organic. Functional TR (FTR) refers to the TR secondary to the left heart pathology or right heart pathology in the face of a normal TV leaflet morphology. The methods of detecting TR have evolved considerably over the years. The …

Abstract 2612: Immediate Clinical And Hemodynamic Benefits Of Restoration Of Pulmonary Valvar Competence In Patients With Pulmonary Hypertension

Background: In patients with severe pulmonary hypertension (PH), chronic pressure overload leads to right heart failure, the main reason for clinical deterioration and mortality. In the presence of pulmonary regurgitation (PR), right ventricular (RV) efficiency and cardiac output are further compromised. Therapeutic options in this patient group are limited due to the high risk of open-heart surgery in the presence of the PH. Percutaneous pulmonary valve implantation (PPVI) may offer a new treatment option for relief of PR without the risk of cardiopulmonary bypass. Methods: Between April 2004 to December 2007, 7 patients with PH (mean PAP &gt; 25 mmHg) due to congenital heart disease and severe PR underwent PPVI. Patients were assigned to New York Heart Association (NYHA) functional classes I – IV. Resting peripheral oxygen saturations were measured. Trans-thoracic echocardiography and magnetic resonance imaging before and after valve implantation was performed. Results: The valve implantation procedure was feasible and uncomplicated in all 7 cases, successfully abolishing PR. There was a significant increase in diastolic (15.4±7.3 to 34.0±8.5 mmHg; p=0.007) and mean (29.7±8.1 to 41.3±12.9 mmHg; p=0.034) pulmonary artery pressures, and an improvement in NYHA functional class (from median IV to median III; p&lt;0.008). Peripheral oxygen saturations rose from 85.9±11.0% to 91.7±8.3% (p=0.036). RV end-diastolic volumes decreased (from 157.0±44.7 to 140.3±53.3 ml/m 2 ), whilst effective RV stroke volume increased (from 23.4±9.3 to 41.0±11.6 ml/m 2 ). During a median follow-up of 20.3 months (range 1.3 – 47.5), competence of the bovine jugular venous valve was well maintained despite near systemic pulmonary pressures. None of the devices were explanted during follow-up. Conclusion: Trans-catheter abolishment of PR in patients with PH is well tolerated and leads to clinical and haemodynamic improvement, most likely due to a combination of increased pulmonary perfusion pressures and RV efficiency. These findings emphasize the detrimental effects of volume overload in chronically pressure overloaded right ventricles.

Retrograde Transarterial Implantation of a Nonmetallic Aortic Valve Prosthesis in High–Surgical-Risk Patients With Severe Aortic Stenosis

Background— To assess the feasibility and safety of retrograde transarterial implantation of a novel nonmetallic aortic valve prosthesis (Direct Flow Medical Inc, Santa Rosa, Calif), a prospective single-center study was performed in patients with severe aortic stenosis at high risk for open-heart surgery. Methods and Results— Fifteen patients (intention-to-treat cohort) with an aortic valve area ≤0.8 cm 2 , a ≥35-mm Hg mean transvalvular pressure gradient, and a logistic EuroSCORE ≥20% were enrolled. Percutaneous aortic valve replacement was performed with the patient under general anesthesia. Hemodynamic parameters were assessed before and after implantation by transesophageal echocardiography. Clinical follow-up and transthoracic echocardiographic assessment were obtained at 30 days. Procedural success was achieved in 12 patients (80%). Surgical conversion became necessary at day 2 in 1 patient; 11 patients (73%) were discharged with a permanent implant. In these patients, implantation resulted acutely in a significant increase in aortic valve area (median, 1.64 [interquartile range, 1.27 to 1.74] versus 0.60 [0.46 to 0.69] cm 2 ; P =0.0033) and a concomitant reduction in the mean pressure gradient (14.0 [13.2 to 16.5] versus 54.0 [43.2 to 59.8] mm Hg; P =0.0033). At 30 days, 1 cardiac death (6.7%; 95% CI, 0.2% to 32.0%) and 1 major stroke were observed. The 10 surviving patients with a permanent implant showed marked hemodynamic and clinical improvement at this time point. Conclusions— In this small series of patients, percutaneous implantation of the Direct Flow Medical aortic valve prosthesis in high–surgical-risk patients was feasible and associated with a reasonably low safety profile.