Ventricular Restoration Research Articles

First-in-man study of Heartech® percutaneous left ventricular partitioning device for treatment of heart failure postmyocardial infarction.

This first-in-man (FIM) study aimed to determine the safety and efficacy of the Heartech® left ventricular partitioning device (LVPD) in patients with chronic heart failure (HF) postmyocardial infarction. Sixteen patients were enrolled from three cardiac intervention centers in China. All patients underwent percutaneous ventricular restoration (PVR) procedures with implantation of the Heartech® LVPD. Safety and immediate success rates were recorded. Major adverse cardiovascular and cerebrovascular events (MACCEs) including all-cause mortality, myocardial infarction, stroke, emergent or selective surgery or interventional therapy, renal failure requiring hemodialysis, and major bleeding were recorded. Efficacy features included functional status, echocardiographic characteristics, life quality characteristics including peak oxygen consumption of cardiopulmonary exercise testing (CPET), European five-dimensional health scale (EQ-5D), 6-min walk test (6MWT) at baseline and during follow-up (NCT02938637). The device success rate was 93.75% (15 successes in 16 patients) with 100% safety. During follow-up of 36 ± 4.5 days, no MACCEs were found. The left ventricular end-systolic volume index decreased significantly (LVESVi, 72.47 ± 22.77 mL/m2 vs. 50.13 ± 13.36 mL/m2 , p < .001) as did left ventricular end diastolic volume index (LVEDVi, 106.27 ± 28.01 mL/m2 vs. 83.20 ± 16.87 mL/m2 , p = .001). Left ventricular ejection fraction (LVEF, 32.47 ± 6.98% vs. 40.41 ± 6.15, p < .001), 6MWT (383.13 ± 108.70 vs. 453.47 ± 88.24, p < 0.001) and EQ-5D (65.93 ± 11.25 vs. 78.67 ± 8.35, p < .001) improved significantly. Heartech® LVPD appeared to be safe and effective for treatment of HF postmyocardial infarction.

Significance of preoperative right ventricular function on mid-term outcomes after surgical ventricular restoration for ischemic cardiomyopathy.

To analyze our surgical experiences with surgical ventricular restoration (SVR) for dilated ischemic cardiomyopathy (ICM) and to determine the significance of preoperative right ventricular (RV) function on outcomes. This study retrospectively analyzed 19 patients who underwent SVR between April 2010 and May 2016. Their mean age and New York Heart Association functional class were 62 ± 11years and 2.9 ± 0.8, respectively. The preoperative mean left ventricular (LV) end-systolic volume index and LV ejection fraction (LVEF) were 134 ± 56mL/m2 and 24 ± 7%, respectively. The preoperative mean RV fractional area change (RVFAC) to quantify RV systolic function was 33 ± 13%, as assessed by transthoracic echocardiography. The mean follow-up period was 47 ± 20months. Three patients died of cardiac causes during the follow-up, with the 3-year and 5-year freedoms from cardiac-related death of 89% and 79%, respectively. Major adverse cardiac events (MACEs) occurred in ten patients, with the 3-year and 5-year MACE-free survival rates of 58% and 41%, respectively. RVFAC (risk ratio [RR] = 0.92, 95% confidence interval [CI] 0.86-0.98, p = 0.01) and LVEF (RR = 0.83, 95% CI 0.68-0.97, p = 0.02) were significant predictors of MACEs in the multivariate analysis. Patients with RVFAC of < 35% had significantly poorer MACE-free survival rates (33% at 3years) than those with RVFAC of ≥ 35% (80% at 3years). SVR for ICM provided acceptable freedom from cardiac-related death; however, MACEs commonly occurred and was associated with RV dysfunction.

Invited Commentary

Invited Commentary

Endoventricular Spiral Plication for Ischemic Dilated Cardiomyopathy

Surgical ventricular restoration (SVR) procedures have been developed; however, their long-term effectiveness remains controversial. Although a series of endoventricular spiral plication (ESP) has been rarely reported and its long prognosis is still unknown; this method has a unique concept of left ventricular (LV) restoration without artificial patch materials. Here, we describe the case of a patient with ischemic cardiomyopathy and ischemic mitral regurgitation who successfully underwent ESP, mitral valve repair, and coronary artery bypass grafting. ESP was effective in papillary muscle approximation for avoiding heart failure; however, the noted improvement of LV wall thickening might be temporary.

Surgical ventricular restoration of the dilated left ventricle with large left ventricular thrombus following acute decompensated heart failure: A late complication of anterior wall myocardial infarction: “Tomb of Dead Myocardium!”

There are various case reports and the original article in the literature about the formation of a left ventricular thrombus (LVT) after acute myocardial infarction as an early to a late sequel. However, there are no guidelines available for their management, as the clinical presentation of LVT is variable and there is no consensus about its management. Furthermore, there are no randomized controlled trials comparing different treatment strategies. Here, we present a case of a large LVT who presented as acute decompensated heart failure. After stabilization, he underwent surgical repair of left ventricular aneurysm and retrieval of a thrombus.

Long-Term Survival and Echocardiographic Findings After Surgical Ventricular Restoration

This study investigates the long-term survival and durability of mitral procedures on patients undergoing surgical ventricular restoration. From 1992 to 2017, 109 patients underwent surgical ventricular restoration. Survival was determined from hospital records and the National Death Index. Preoperative demographics, clinical characteristics and features, operative technique, and follow-up echocardiography findings were analyzed using Cox regression and log-rank to determine variables influencing survival. The mean age was 61.57 ± 12.81 years. There were 101 (93%) true and 8 (7%) pseudo-aneurysms. Concomitant surgeries included mitral valve (MV) repair (n= 40, 37%), MV replacement (n= 5, 5%), tricuspid valve repair (n= 4, 4%), aortic valve replacement (n= 3, 3%), coronary bypass grafting (n= 76, 70%; 1.6 ± 1.3 grafts), and ventricular septal defect closure (n= 5, 5%). Redo-sternotomies were performed in 12 patients (11%). Median duration of echocardiographic follow up was 2.9 years (interquartile range, 9.0) and was obtained in 59 patients (54%). Left ventricular ejection fraction improved from 28% ± 13% to 33% ± 16% (p= 0.011). Median duration of echocardiographic follow-up of MV repair was 3.6 years (interquartile range, 9.5). MV repair led to sustained improvements in mitral regurgitation (MR; p= 0.001) where only 2 (5%) experienced recurrence of moderate to severe MR. For patients who did not undergo an MV procedure there was no difference in preoperative and follow-up MR severity (p= 0.586). Median patient follow-up was 7.1 years (interquartile range, 8.5). Overall 5-, 10-, and 15-year survival rates were 71.9%, 48.1%, and 26.2%, respectively. Surgical ventricular restoration was associated with sustained improvement in left ventricular ejection fraction with almost half surviving to 10 years postoperatively. For patients undergoing concomitant MV repair, the improvement in mitral competence is durable.

Left ventricular reconstruction surgery in ischemic heart disease: a systematic review of the past two decades.

The aim of this paper is to systematically review the existing literature reporting on patients recruited during the past twenty years regarding the role of left ventricular (LV) reconstruction in ischemic cardiomyopathy in terms of efficacy and mortality and provide an updated overview of the current evidence. The PubMed and Cochrane bibliographical databases were thoroughly searched for the following MeSH terms: "ventricular reconstruction" OR ventriculoplasty OR "ventricular aneurysm" OR "ventricular restoration." Original studies -recruiting patients during the past twenty years- on LV reconstruction surgery in more than five cases and reporting on the associated peri- or postoperative mortality were deemed eligible. Twenty-seven studies were included and provided data for 3220 patients with a mean age of 61 years. Angina was present in 66.6% (510/766) of the patients, while nine out of ten (635/699) had a history of myocardial infarction. Average preoperative ejection fraction was 29.9% and end-systolic volume index was 93.6 mL/m2. With respect to complications, low cardiac output syndrome and the need for intra-aortic balloon pump were prevalent in 9.3% (79/850) and 18.8% (334/1773), respectively. Thirty-day mortality was 7.1% (230/3220) and late-mortality (mean follow-up of 36.9 months) was 19.6% (548/2791), while the rate of MACCE was 40.1% (367/915). Five-year mortality was 29% (340/1171). Our findings provide a current perspective of the role of LV reconstruction in the treatment of ischemic cardiomyopathy suggesting its benefit in survival. Taking into consideration the existing debate, further studies are required so that a solid conclusion to be made.

A Case of Surgical Ventricular Restoration with Heparin-Induced Thrombocytopenia Type II

A Case of Surgical Ventricular Restoration with Heparin-Induced Thrombocytopenia Type II

Role of surgical ventricular restoration post surgical treatment of heart failure (STICH) trial.

To compare the outcomes of isolated coronary artery bypass grafting (CABG) versus surgical ventricular restoration (SVR) with or without CABG for patients with ischemic cardiomyopathy (ICM). Retrospectively, 49 patients with ICM and severe LV dysfunction (LVEF < 35%) who underwent SVR with or without CABG from January 2009 to December 2016 at a single institution was compared with 49 patients who underwent isolated CABG. The two groups were matched for preoperative clinical and echocardiographic parameters including left ventricular end-diastolic diameter (LVIDd), left ventricular end-systolic diameter (LVIDs), left ventricular ejection fraction (LVEF), left ventricular end-diastolic volume (LVEDV), and left ventricular end-systolic volume (LVESV). Primary outcomes analyzed included early mortality, late mortality, and major adverse cardiac or cerebrovascular events (MACCE). Secondary outcomes analyzed included echocardiographic parameters of left ventricular volume and function-indexed left ventricular end-diastolic volume (LVEDVi), indexed left ventricular end-systolic volume (LVESVi), and LVEF. Cox and survival analysis was performed. Early and late mortality in SVR vs. CABG groups were 4 (8.1%) and 6 (12.2%) vs. 1 (2%) and 5 (10.2%) respectively. Mean improvement in LVEF was 3.39 ± 7.51 compared to 4.97 ± 5.45 between the two groups at 3-month follow-up. Mean improvement in LVEF was 5.1 ± 8.3 in the SVR group vs 5.9 ± 7.1 in the CABG group at the last follow-up. There was no statistically significant improvement between the two groups in terms of LVEF at 3months or the last follow-up. There were statistically significant differences between LVEDVi and LVESVi between the two groups at 3months and the last follow-up. The 5-year rates of survival were 85 ± 6 and 82 ± 9% for SVR and CABG groups respectively. The 5-year rates of freedom from MACCE were 75 ± 7 and 60 ± 11% for SVR and CABG groups respectively. Compared with isolated CABG, SVR plus CABG results in equivalent late mortality and better left ventricular reverse remodeling (as evidenced by LV volume reduction) and better freedom from MACCE at 5-year follow-up.

Label-free Evaluation of Myocardial Infarct in Surgically Excised Ventricular Myocardium by Raman Spectroscopy

Understanding the viability of the ischemic myocardial tissue is a critical issue in determining the appropriate surgical procedure for patients with chronic heart failure after myocardial infarction (MI). Conventional MI evaluation methods are; however, preoperatively performed and/or give an indirect information of myocardial viability such as shape, color, and blood flow. In this study, we realize the evaluation of MI in patients undergoing cardiac surgery by Raman spectroscopy under label-free conditions, which is based on intrinsic molecular constituents related to myocardial viability. We identify key signatures of Raman spectra for the evaluation of myocardial viability by evaluating the infarct border zone myocardium that were excised from five patients under surgical ventricular restoration. We also obtain a prediction model to differentiate the infarcted myocardium from the non-infarcted myocardium by applying partial least squares regression-discriminant analysis (PLS-DA) to the Raman spectra. Our prediction model enables identification of the infarcted tissues and the non-infarcted tissues with sensitivities of 99.98% and 99.92%, respectively. Furthermore, the prediction model of the Raman images of the infarct border zone enabled us to visualize boundaries between these distinct regions. Our novel application of Raman spectroscopy to the human heart would be a useful means for the detection of myocardial viability during surgery.

Impact of surgical ventricular restoration on early and long-term outcomes of patients with left ventricular aneurysm: A single-center experience.

Left ventricular aneurysm (LVA) is a common complication of myocardial infarction. However, the optimal treatment for LVA remains controversial.In this retrospective study, we analyzed the early and long-term clinical consequences of surgical ventricular restoration on 102 patients who had undergone repair between January, 2005 and January, 2015. The LVA repair approaches comprised of patch plasty (n = 28), linear repair (n = 40), and plication repair (n = 34).Patient demographics were 60.8% male, and the mean age was 60.5 ± 7.2 years. The in-hospital mortality rate was 7.8% (8/102), including 6 patients who died from low cardiac output and 2 from multiorgan failure. During the early postoperative period, left ventricular sizes significantly decreased in the patch plasty and linear repair groups compared with the plication group. In addition, all 3 repair techniques greatly ameliorated left ventricular ejection fraction (P < .05), and there was no significant difference in survival rate between groups (P = .25).Surgical ventricular restoration (linear repair, plication repair, and patch plasty) obtained equivalently appreciable outcomes for cardiac function improvement, perioperative mortality, and survival. Selection of a surgical technique for LVA patients should be optimized to individual patient conditions including the morphological characteristics of the aneurysm and ischemic scar.

Cell therapy and left ventricular restoration for ischemic cardiomyopathy: long-term results of a perspective, randomized study.

Aim of this study is to verify the potential advantages and benefits of bone-marrow derived autologous stem cells implantation associated to surgical left ventricular restoration (SVR), to report a new modality of cell delivery to myocardium, and to identify possible side effects of this procedure. Between March 2007 and March 2013, 30 patients affected by ischemic dilative cardiomyopathy who received a SVR operation were enrolled in the study. The population was divided in two groups:16 patients were randomly assigned to receive stem cells therapy in addition to SVR (groupA), 14 patients received a placebo (group B). The two groups were homogeneous in respect of age, gender, preoperative NYHA class, mitral incompetence and left ventricular sizes and volumes. The patients were evaluated by echo and pet-scan before surgery and at 6 months follow-up, and by echo at subsequent follow-up. Overall 30 days-in hospital mortality was 0 for the entire cohort. At last follow-up ejection fraction increased from 25.3% before surgery to 36.3% in group A, and from 31.8% to 45.6% in group B. Reduction of LVEDD was 6% in group A, 9% in group B. ESLVV and EDLVD decreased more significantly in patients receiving stem cells (55% vs. 35%). Late cardiac mortality at 9 years follow-up was similar in the two groups of patients. No early or late adverse reaction nor cases of infections were observed. Patients affected by ischemic cardiomyopathy have a favourable outcome after SVR. A higher reduction of LVEDV and LVESV assessed by CT-Scan evaluation in patients receiving cell therapy, when compared to control group, encourages the evolution and refinement of myocardial regenerative therapy added to SVR.

Assessment of left ventricular hemodynamics and systolic function in patients with apical aneurysm after percutaneous ventricular restoration by echocardiography

Objective To evaluate the changes of left ventricular hemodynamics and systolic function in patients with apical aneurysm after percutaneous ventricular restoration(PVR) by echocardiography. Methods Fifty patients with apical aneurysm were divided into PVR group (25 cases) and conservative treatment group(control group, 25 cases). Two-dimensional transthoracic echocardiography(2D-TTE) combined with real-time three-dimensional transesophageal echocardiography(RT-3DTEE) were applied for all the subjects in PVR group on preoperative, one week after operaction, three months after operaction and in control group on initial stage of prevent ventricular remodeling therapy, one week after therapy, three months after therapy to obtain left ventricular end-diastolic diameter(LVEDD), left ventricular end-systolic diameter(LVSDD), left ventricular end-diastolic volume(EDV), end-systolic volume(ESV), left ventricular ejection fraction(LVEF), left ventricular fractional shortening(LVFS), body surface area(BSA), stroke volume(SV), stroke volume index(SVI), cardiac output(CO), cardiac output index(CI). Results There were significant differences in all parameters(P 0.05). Compared with preoperative, there was no difference in all parameters in the following one week after operaction(P>0.05), there was significant increase in SV and significant reduce in LVEDD and EDV (P 0.05). For the control group there was no significant difference between initial stage of prevevt ventricular remodeling therapy and in the following one week or three months after operaction. Conclusions PVR has a definite effect on left ventricular hemodynamics and systolic function in patients with apical aneurysm in the short term, while 2D-TTE and RT-3DTEE provides a reliable basis for clinical to evaluate the effect of the PVR. Key words: Echocardiography; Apical aneurysm; Percutaneous ventricular restoration; Ventricular function, left; Hemodynamics

Vasoplegia After Surgical Left Ventricular Restoration: 2-Year Follow-Up

Vasoplegia is a severe complication that can develop after surgical procedures for heart failure. The current study evaluated the effect of vasoplegia on survival, cardiac function, and renal function 2 years after surgical left ventricular restoration (SVR). Heart failure patients with a left ventricular ejection fraction (LVEF) of 0.35 or less who underwent SVR in 2006 to 2014 were included. Vasoplegia was defined as the continuous need of vasopressors (norepinephrine ≥0.2 μg · kg-1 · min-1 or terlipressin [any dose], or both) combined with a cardiac index of 2.2 L · min-1 · m-2 or higher for at least 12 consecutive hours, starting within the first 3 days postoperatively. The effect of vasoplegia on mortality, New York Heart Association Functional Classification, LVEF, and creatinine clearance was assessed up to 2 years of follow-up. SVR was performed in 113 patients (80% men), aged 62 ± 10 years, and with an LVEF of 0.25 ± 0.06. Postoperative vasoplegia developed in 23%. Survival was lower in patients with vasoplegia compared with patients without vasoplegia at 6 months (62% vs 90%, p= 0.001) and at 2 years (50% versus 84%, p < 0.001). At the 2-year follow-up, New York Heart Association class and LVEF had improved and were similar in both groups (respectively, p= 0.319 and p= 0.444). Creatinine clearance was lower in patients with vasoplegia compared with patients without vasoplegia 2 years postoperatively (p < 0.001), even after correcting for baseline creatinine clearance (p= 0.009). Vasoplegia after SVR is associated with decreased survival. Despite an improved and similar cardiac function, renal function was compromised in vasoplegic patients at the 2-year follow-up.

P5641CMR and 4dflow-based analysis of alterations in post ischemic dilated cardiomiopathy before and after surgical ventricular restoration

P5641CMR and 4dflow-based analysis of alterations in post ischemic dilated cardiomiopathy before and after surgical ventricular restoration

Regression of Diffuse Ventricular FibrosisFollowing Restoration of SinusRhythm With Catheter Ablation inPatients With Atrial Fibrillation andSystolic Dysfunction: A Substudy of the CAMERA MRI Trial.

This study sought to determine if diffuse ventricular fibrosis improves in patients with atrial fibrillation (AF)-mediated cardiomyopathy following the restoration of sinus rhythm. AF coexists in 30% of heart failure (HF) patients and may be an underrecognized reversible cause of left ventricular systolic dysfunction. Myocardial fibrosis is the hallmark of adverse cardiac remodeling in HF, yet its reversibility is unclear. Patients with persistent AF and an idiopathic cardiomyopathy (left ventricular ejection fraction [LVEF]≤45%) were randomized to catheter ablation (CA) or ongoing medical rate control as a pre-specified substudy of the CAMERA-MRI (Catheter Ablation versus Medical Rate Control in Atrial Fibrillation and Systolic Dysfunction-an MRI-Guided Multi-centre Randomised Controlled Trial) trial. All patients had cardiac magnetic resonance imaging scans (including myocardial T1 time), serum B-type natriuretic peptide, 6-min walk tests, and Short Form-36 questionnaires performed at baseline and 6 months. Sixteen patients with no history of AF or left ventricular systolic dysfunction were enrolled as normal controls for T1 time. Thirty-six patients (18 in each treatment arm) were included in this substudy. Demographics, comorbidities, and myocardial T1 times were well matched at baseline. At 6 months, patients in the CA grouphad a significant reduction in myocardial T1 time from baseline compared with the medical rate control group (-124 ms; 95% confidence interval [CI]:-23 to-225 ms; p= 0.0176), although it remained higher than that of normal controls at 6 months (p= 0.0017). Improvements in myocardial T1 time with CA were associatedwith significant improvements in absolute LVEF (+12.5%; 95% CI: 5.9% to 19.0%; p= 0.0004), left ventricular end-systolic volume (p= 0.0019), and serum B-type natriuretic peptide (-216 ng/l; 95% CI:-23 to-225 ng/l; p= 0.0125). The improvement in LVEF and reverse ventricular remodeling following successful CA ofAF-mediated cardiomyopathy is accompanied by a regression of diffuse fibrosis. This suggests timely treatmentof arrhythmia-mediated cardiomyopathy may minimize irreversible ventricular remodeling.

Increased Short-Term and Mid-Term Major Complications Were Observed in Elderly Patients with Renal Dysfunction after Surgical Ventricular Restoration.

This study was conducted to explore the impact of renal dysfunction on short-term and mid-term outcomes in elderly patients. Patients over 65 years of age receiving surgical ventricular restoration (SVR) were included in the study. They were stratified through estimated glomerular filtration rate (eGFR), with a cutoff point of 60 mL/min/1.73m2. Risk-adjusted analysis, including propensity score matching, was carried out to compare short-term and mid-term outcomes between the two groups of patients. From January 1999 to December 2015, a total of 280 elderly patients underwent SVR. Of the patients, 79 had eGFR lower than 60 mL/min/1.73m2 and were considered to have renal dysfunction. Mortality was higher in the renal dysfunction group than the normal renal function group, with marginal significance (adjusted P value = .06). The need for mechanical supports (adjusted P value = .04) was higher in the renal dysfunction group. Hemofiltration (adjusted P value < .01) and requirements for transfusion (adjusted P value = .03) were significantly higher in the renal dysfunction group than in the group with normal renal function. The presence of renal dysfunction was associated with higher risk of major adverse cerebro-cardiovascular events (MACCE) than normal renal function (HR = 2.34, 95% CI = 1.34 - 4.08, P = .003). Compared to patients with normal renal function, elderly SVR patients with renal failure have a higher incidence of short-term mechanical support, mid-term mortality, and MACCE events.

Lower Senescence of Adipose-Derived Stem Cells than Donor-Matched Bone Marrow Stem Cells for Surgical Ventricular Restoration.

Surgical ventricular reconstruction (SVR) can restore cardiac function for left ventricular aneurysm to some extent. However, the patches used in this treatment have some limitations such as stiffness and calcification. Engineering heart tissues (EHTs) have emerged as a promising biomaterial to repair damaged heart. Nevertheless, selecting optimal candidate cells for EHTs has been controversial. Aging is a major consideration for seed cells derived from elderly patients. Hence, this study was aimed to assess the proliferation of, antiapoptosis potential of, and expression of senescence-associated factors (eg, SA-β-Gal, cyclin-dependent kinase inhibitor 2A (P16), cyclin-dependent kinase inhibitor 1 (P21) in adipose-derived stem cells (ADSCs), and bone marrow stem cells (BMSCs) in vitro. In addition, cardiac function, cell survival, and angiogenesis of ADSCs and BMSCs after SVR were assessed in vivo. The in vitro results showed that old ADSCs (OAs) grew faster; expressed lower levels of SA-β-Gal, P16, and P21; and possessed more pronounced antiapoptosis activity than old BMSCs (OBs). The in vivo results demonstrated that 28 days after patch implantation, animals that received OAs patches showed better restoration of cardiac function than animals that received OBs patches. Meanwhile, old ADSCs possessed more potential regarding cell survival and angiogenesis. These results suggest that ADSCs may be superior to BMSCs with regard to autologous cell transplantation in elderly patients.

OP-10 - The İnitial Experience with Left Ventricular Restoration and Coronary Artery Bypass Grafting

OP-10 - The İnitial Experience with Left Ventricular Restoration and Coronary Artery Bypass Grafting

Does surgical ventricular restoration still represent a valuable option in the surgeon's armamentarium in the post-STICH era?

Does surgical ventricular restoration still represent a valuable option in the surgeon's armamentarium in the post-STICH era?