Percutaneous repair of moderate-to-severe or severe functional mitral regurgitation in patients with symptomatic heart failure: Baseline characteristics of patients in the RESHAPE-HF2 trial and comparison to COAPT and MITRA-FR trials.

AIM: The RESHAPE-HF2 trial is designed to assess the efficacy and safety of the MitraClip device system for the treatment of clinically important functional mitral regurgitation (FMR) in patients with heart failure (HF). This report describes the baseline characteristics of patients enrolled in the RESHAPE-HF2 trial compared to those enrolled in the COAPT and MITRA-FR trials. METHODS AND RESULTS: The RESHAPE-HF2 study is an investigator-initiated, prospective, randomized, multicentre trial including patients with symptomatic HF, a left ventricular ejection fraction (LVEF) between 20% and 50% with moderate-to-severe or severe FMR, for whom isolated mitral valve surgery was not recommended. Patients were randomized 1:1 to a strategy of delivering or withholding MitraClip. Of 506 patients randomized, the mean age of the patients was 70 ± 10 years, and 99 of them (20%) were women. The median EuroSCORE II was 5.3 (2.8-9.0) and median plasma N-terminal pro-B-type natriuretic peptide (NT-proBNP) was 2745 (1407-5385) pg/ml. Most patients were prescribed beta-blockers (96%), diuretics (96%), angiotensin-converting enzyme inhibitors/angiotensin receptor blockers/angiotensin receptor-neprilysin inhibitors (82%) and mineralocorticoid receptor antagonists (82%). The use of sodium-glucose cotransporter 2 inhibitors was rare (7%). Cardiac resynchronization therapy (CRT) devices had been previously implanted in 29% of patients. Mean LVEF, left ventricular end-diastolic volume and effective regurgitant orifice area (EROA) were 31 ± 8%, 211 ± 76 ml and 0.25 ± 0.08 cm2, respectively, whereas 44% of patients had mitral regurgitation severity of grade 4+. Compared to patients enrolled in COAPT and MITRA-FR, those enrolled in RESHAPE-HF2 were less likely to have mitral regurgitation grade 4+ and, on average, HAD lower EROA, and plasma NT-proBNP and higher estimated glomerular filtration rate, but otherwise had similar age, comorbidities, CRT therapy and LVEF. CONCLUSION: Patients enrolled in RESHAPE-HF2 represent a third distinct population where MitraClip was tested in, that is one mainly comprising of patients with moderate-to-severe FMR instead of only severe FMR, as enrolled in the COAPT and MITRA-FR trials. The results of RESHAPE-HF2 will provide crucial insights regarding broader application of the transcatheter edge-to-edge repair procedure in clinical practice.

Prevalence, mortality, cost, and disparities in transcatheter mitral valve repair and replacement in cancer patients: Artificial intelligence and propensity score national 5-year analysis of 7495 procedures.

INTRODUCTION: We conducted the first comprehensive evaluation of the therapeutic value and safety profile of transcatheter mitral edge-to-edge repair (TEER) and transcatheter mitral valve replacement (TMVR) in individuals concurrently afflicted with cancer. METHODS: Utilizing the National Inpatient Sample (NIS) dataset, we analyzed all adult hospitalizations between 2016 and 2020 (n = 148,755,036). The inclusion criteria for this retrospectively analyzed prospective cohort study were all adult hospitalizations (age 18 years and older). Regression and machine learning analyses in addition to model optimization were conducted using ML-PSr (Machine Learning-augmented Propensity Score adjusted multivariable regression) and BAyesian Machine learning-augmented Propensity Score (BAM-PS) multivariable regression. RESULTS: Of all adult hospitalizations, there were 5790 (0.004%) TMVRs and 1705 (0.001%) TEERs. Of the total TMVRs, 160 (2.76%) were done in active cancer. Of the total TEERs, 30 (1.76%) were done in active cancer. After the comparable rates of TEER/TMVR in active cancer in 2016, the prevalence of TEER/TMVR was significantly less in active cancer from 2017 to 2020 (2.61% versus 7.28% p < 0.001). From 2017 to 2020, active cancer significantly decreased the odds of receiving TEER or TMVR (OR 0.28, 95%CI 0.13-0.68, p = 0.008). In patients with active cancer who underwent TMVR/TEER, there were no significant differences in socio-economic disparities, mortality or total hospitalization costs. CONCLUSION: The presence of malignancy does not contribute to increased mortality, length of stay or procedural costs in TMVR or TEER. Whereas the prevalence of TMVR has increased in patients with active cancer, the utilization of TEER in the context of active cancer is declining despite a growing patient population.

Comparison of American and European Guidelines for the Management of Patients With Valvular Heart Disease.

This review compares the recommendations of the recent 2020 American College of Cardiology (ACC)/American Heart Association (AHA) and 2021 European Society of Cardiology (ESC)/European Association for Cardio-Thoracic Surgery (EACTS) guidelines on the management of patients with valvular heart disease (VHD). ACC/AHA and ESC/EACTS guidelines are both the updated versions of previous 2017 documents. Both guidelines fundamentally agree on the extended indications of percutaneous valve interventions, the optimal use of imaging modalities other than 2D echocardiography, the importance of a multidisciplinary Heart Team as well as active patient participation in clinical decision making, more widespread use of NOACs and earlier intervention with lower left ventricular dilatation thresholds to decrease long-term mortality. The differences between the guidelines are mainly related to the classification of the severity of valve pathologies and frequency of follow-up, level of recommendations of valve intervention indications in special patient groups such as frail patients and the left ventricular diameter and ejection fraction thresholds for intervention.

Conservative, surgical, and percutaneous treatment for mitral regurgitation shortly after acute myocardial infarction.

AIMS: Severe mitral regurgitation (MR) following acute myocardial infarction (MI) is associated with high mortality rates and has inconclusive recommendations in clinical guidelines. We aimed to report the international experience of patients with secondary MR following acute MI and compare the outcomes of those treated conservatively, surgically, and percutaneously. METHODS AND RESULTS: Retrospective international registry of consecutive patients with at least moderate-to-severe MR following MI treated in 21 centres in North America, Europe, and the Middle East. The registry included patients treated conservatively and those having surgical mitral valve repair or replacement (SMVR) or percutaneous mitral valve repair (PMVR) using edge-to-edge repair. The primary endpoint was in-hospital mortality. A total of 471 patients were included (43% female, age 73 ± 11 years): 205 underwent interventions, of whom 106 were SMVR and 99 PMVR. Patients who underwent mitral valve intervention were in a worse clinical state (Killip class ≥3 in 60% vs. 43%, P < 0.01), but yet had lower in-hospital and 1-year mortality compared with those treated conservatively [11% vs. 27%, P < 0.01 and 16% vs. 35%, P < 0.01; adjusted hazard ratio (HR) 0.28, 95% confidence interval (CI) 0.18-0.46, P < 0.01]. Surgical mitral valve repair or replacement was performed earlier than PMVR [median of 12 days from MI date (interquartile range 5-19) vs. 19 days (10-40), P < 0.01]. The immediate procedural success did not differ between SMVR and PMVR (92% vs. 93%, P = 0.53). However, in-hospital and 1-year mortality rates were significantly higher in SMVR than in PMVR (16% vs. 6%, P = 0.03 and 31% vs. 17%, P = 0.04; adjusted HR 3.75, 95% CI 1.55-9.07, P < 0.01). CONCLUSIONS: Early intervention may mitigate the poor prognosis associated with conservative therapy in patients with post-MI MR. Percutaneous mitral valve repair can serve as an alternative for surgery in reducing MR for high-risk patients.

Safety and Feasibility of MitraClip Implantation in Patients with Acute Mitral Regurgitation after Recent Myocardial Infarction and Severe Left Ventricle Dysfunction.

Patients with severe mitral regurgitation (MR) after myocardial infarction (MI) have an increased risk of mortality. Transcatheter mitral valve repair may therefore be a suitable therapy. However, data on clinical outcomes of patients in an acute setting are scarce, especially those with reduced left ventricle (LV) dysfunction. We conducted a multinational, collaborative data analysis from 21 centers for patients who were, within 90 days of acute MI, treated with MitraClip due to severe MR. The cohort was divided according to median left ventricle ejection fraction (LVEF)-35%. Included in the study were 105 patients. The mean age was 71 ± 10 years. Patients in the LVEF < 35% group were younger but with comparable Euroscore II, multivessel coronary artery disease, prior MI and coronary artery bypass graft surgery. Procedure time was comparable and acute success rate was high in both groups (94% vs. 90%, p = 0.728). MR grade was significantly reduced in both groups along with an immediate reduction in left atrial V-wave, pulmonary artery pressure and improvement in New York Heart Association (NYHA) class. In-hospital and 1-year mortality rates were not significantly different between the two groups (11% vs. 7%, p = 0.51 and 19% vs. 12%, p = 0.49) and neither was the 3-month re-hospitalization rate. In conclusion, MitraClip intervention in patients with acute severe functional mitral regurgitation (FMR) due to a recent MI in an acute setting is safe and feasible. Even patients with severe LV dysfunction may benefit from transcatheter mitral valve intervention and should not be excluded.

Floppy mitral valve/mitral valve prolapse syndrome: Beta-adrenergic receptor polymorphism may contribute to the pathogenesis of symptoms.

BACKGROUND: Certain patients with floppy mitral valve (FMV)/mitral valve prolapse (MVP) may have symptoms that cannot be explained on the severity of mitral valvular regurgitation (MVR) alone; hypersensitivity to adrenergic stimulation has been suggested in this group defined as the FMV/MVP syndrome. METHODS: Ninety-eight patients (75 men, 23 women) with mitral valve surgery for FMV/MVP were studied. Of those 41 (42%) had symptoms consistent with FMV/MVP syndrome [29 men (39%), 12 women (52%)]; median age of symptom onset was 30 years (range 10-63 years) and median duration of symptoms prior to valve surgery was 16 years (range 3-50 years). Ninety-nine individuals (70 men, 29 women) without clinical evidence of any disease were used as controls. Genotyping of ß1 and ß2 adrenergic receptors was performed. RESULTS: ß-Adrenergic receptor genotypes (ß1 and ß2) were similar between control and overall FMV/MVP patients. Subgroup analysis of patients, however, demonstrated that the genotype C/C at position 1165 resulting in 389 Arg/Arg of the ß1 receptor was more frequent in women compared to those without FMV/MVP syndrome and to normal control women (p<0.025). This polymorphism may be related to hypersensitivity to adrenergic stimulation as reported previously in these patients. CONCLUSION: This study shows a large proportion of patients with FMV/MVP, predominantly women, had symptoms consistent with the FMV/MVP syndrome for many years prior to the development of significant MVR, and thus symptoms cannot be attributed to the severity of MVR alone. Further, women with FMV/MVP syndrome, symptoms at least partially may be related to ß1-adrenergic receptor polymorphism, which has been shown previously to be associated with a hyperresponse to adrenergic stimulation.

Percutaneous closure of atrial septal defects: immediate and mid-term results.

INTRODUCTION: The incidence of percutaneous closure of secundum atrial septal defects (ASD) and patent foramen ovale (PFO), which has become an established therapy, is constantly increasing. In this study, which is the first in the Greek literature, we present the immediate and mid-term results from this intervention in our center. METHODS: From April 2004 to April 2008, 103 patients underwent percutaneous closure of an ASD or PFO using Amplatzer closure devices. Thirty were male, the mean age was 37 +/- 15.5 years, and the mean follow-up period 21.7 +/- 14.8 months. The procedure was successful in 102 of the above patients; 69 (mean age 36.3 years +/- 17.1, 81% female) underwent secundum ASD closure, while 33 patients (mean age 39.1 +/- 10.5 years, 16 female and 17 male) underwent percutaneous closure of a PFO due to cryptogenic stroke. RESULTS: There were no major complications during the procedure (death, device embolization or need for immediate cardiac surgery). There were minor complications in 8 (7.7%) patients (bleeding at the puncture site, transient ST elevation in the inferior leads, multiple atrial and ventricular ectopics). The transient ST elevation in the inferior leads appeared in 5 patients (5%) and was probably due to air embolization. This transient complication completely resolved within 3 minutes. During the follow-up period, no patient had a major complication (cardiac rupture, device embolization, thrombus formation, thromboembolism or infective endocarditis). Most importantly, in the patients who underwent PFO closure there were no recurrences of cryptogenic stroke during the follow-up period (24.3 +/- 14.5 months). CONCLUSIONS: This study shows that using Amplatzer closure devices for atrial septal communications is both safe and effective, with sustained results over a maximum follow-up period of four years. Appropriate patient selection, as well as accurate device sizing fitting the dimensions of the defect, are important factors for the success and the safety of the method.

Left atrial function and work after surgical ventricular restoration in postmyocardial infarction heart failure.

INTRODUCTION: The purpose of the current study was to examine the effect of surgical ventricular restoration in left atrial (LA) performance and left ventricular (LV) diastolic function in patients with congestive heart failure after extensive anterior myocardial infarction. METHODS: Seventeen consecutive patients (age 63 +/- 9 years, 14 male, 4 with diabetes) were studied prospectively. All patients underwent surgical ventricular restoration and concomitant coronary artery bypass surgery. LA volumes were calculated, as were peak LA kinetic energy (LAKE) and LA ejection fraction (LAEF). LV diastolic filling patterns were also assessed. RESULTS: Follow-up period was 1 year. LA size and volumes did not change significantly during the follow-up period. Two distinct groups of patients were identified: group A, in which LAEF and peak LAKE increased, and group B, in which LAEF and peak LAKE decreased. In both groups, the LAEF and peak LAKE appeared to increase or decrease simultaneously and this became evident from the first month after the surgery. However, 1 year after the operation, diastolic filling pattern was significantly different between the two groups. LA function showed improvement only in patients who demonstrated an improvement in indices of diastolic filling pattern. CONCLUSIONS: Despite improvement in clinical status and indices of LV systolic function in all patients who underwent surgical ventricular restoration for treatment of congestive heart failure as a result of LV dilatation secondary to large myocardial infarction, improvement of LA function occurs in patients with improved LV diastolic function.

Diverticulum of the left ventricle: etiology and surgical treatment.

Congenital left ventricular (LV) diverticula are rare findings, particularly when first diagnosed in adulthood. We describe successful surgical repair of an isolated congenital apical LV diverticulum associated with an abnormal submitral apparatus in a young adult who received his diagnosis following a peripheral embolism. We intraoperatively identified an abnormally originating belly of the posteromedial papillary muscle, which arose from the interventricular septum, causing partition of the LV cavity and forming an apical aneurysmal communicating chamber. This anatomy of abnormal papillary muscle bifurcation was possibly the mechanism for the development of the apical diverticulum and to the best of our knowledge has not previously been described. Reattachment of the abnormal belly to its normal position preserved mitral valve competence, and an endoventricular patch repair restored LV volume and geometry.

First human implantation of a new rotary blood pump: design of the clinical feasibility study.

Surgical treatment of heart failure is emerging as one of the most challenging clinical dilemmas for patients with end-stage cardiac failure not amenable to medical treatment. One of the most intriguing techniques is the use of implantable left ventricular assist devices (LVADs) as a bridge to recovery. The early experience from our centre has shown that even short term post-cardiotomy mechanical assistance, after heart failure surgery, improves patient outcome; thus, a clinical feasibility study was designed. The hypothesis of the study is that reparative heart failure surgery combined with postoperative mechanical support, ventricular resynchronisation where indicated, and pharmacological treatment can maximise myocardial recovery. In the study a new, implantable, magnetically levitated, rotary pump will be used as a bridge to recovery. In this manuscript the first worldwide human implantation of a new, continuous-flow LVAD, the WorldHeart Rotary Pump (Levacor, WorldHeart Inc., Oakland CA), is reported. The design and the rationale of the feasibility study, the inclusion and exclusion criteria, and the primary and secondary end points of the clinical investigation, are delineated. In addition, the design of the new rotary pump, its general principles of operation, and the implantation technique are described.