Hospitalization of Symptomatic Patients With Heart Failure and Moderate to Severe Functional Mitral Regurgitation Treated With MitraClip: Insights From RESHAPE-HF2.

BACKGROUND: For patients with functional mitral regurgitation (FMR) and symptomatic heart failure (HF), randomized trials of mitral transcatheter edge-to-edge repair (M-TEER) have produced conflicting results. OBJECTIVES: This study sought to assess the impact of M-TEER on hospitalization rates, and explore the effects of M-TEER on patients who did or did not have a history of recent HF hospitalizations before undergoing M-TEER. METHODS: RESHAPE-HF2 (Randomized Investigation of the MitraClip Device in Heart Failure: 2nd Trial in Patients with Clinically Significant Functional Mitral Regurgitation) included patients with symptomatic HF and moderate to severe FMR (mean effective regurgitant orifice area 0.25 cm2; 14% >0.40 cm2, 23% <0.20 cm2) and showed that M-TEER reduced recurrent HF hospitalizations with and without the addition of cardiovascular (CV) death and improved quality of life. We now report the results of prespecified analyses on hospitalization rates and for the subgroup of patients (n = 333) with a HF hospitalization in the 12 months before randomization. RESULTS: At 24 months, the time to first event of CV death or HF hospitalization (HR: 0.65; 95% CI: 0.49-0.85; P = 0.002), the rate of recurrent CV hospitalizations (rate ratio [RR]: 0.75; 95% CI: 0.57-0.99; P = 0.046), the composite rate of recurrent CV hospitalizations and all-cause mortality (RR: 0.74; 95% CI: 0.57-0.95; P = 0.017), and of recurrent CV death and CV hospitalizations (RR: 0.76; 95% CI: 0.58-0.99; P = 0.040), were all lower in the M-TEER group. The RR of recurrent hospitalizations for any cause was 0.82 (95% CI: 0.63-1.07; P = 0.15) for patients in the M-TEER group vs control group patients. Patients randomized to M-TEER lost fewer days due to death or HF hospitalization (13.9% [95% CI: 13.0%-14.8%] vs 17.4% [95% CI: 16.4%-18.4%] of follow-up time; P < 0.0001, and 1,067 vs 1,776 total days lost; P < 0.0001). Patients randomized to M-TEER also had better NYHA functional class at 30 days and at 6, 12, and 24 months of follow-up (P < 0.0001). A history of HF hospitalizations before randomization was associated with worse outcomes and greater benefit with M-TEER on the rate of the composite of recurrent HF hospitalizations and CV death (Pinteraction = 0.03) and of recurrent HF hospitalizations within 24 months (Pinteraction = 0.06). CONCLUSIONS: These results indicate that a broader application of M-TEER in addition to optimal guideline-directed medical therapy should be considered among patients with symptomatic HF and moderate to severe FMR, particularly in those with a history of a recent hospitalization for HF.

Pushing the hybrid approach to the edges, three stories in one: a case report.

Background: Mitral annular calcification (MAC) is common in the elderly. Extensive calcification has been historically challenging for the cardiac surgeons, with traditional surgical approaches carrying significant risks. Less invasive approaches have recently been explored in an attempt to reduce this risk. Case summary: We report the case of a 75-year-old woman who presented with recurrent pulmonary oedema, due to severe MAC and mitral regurgitation. Her past medical history included bioprosthetic aortic valve replacement 5 years ago. Given the extensive MAC and the patient's frailty, a minimally invasive hybrid approach with direct implantation of a transcatheter balloon expandable Sapien 3 valve was selected to manage her. Although the post-surgical result was initially excellent with elimination of the mitral regurgitation, the patient's post-operative course was marked by two serious complications, namely, acute severe aortic regurgitation, due to rupture of the bioprosthetic valve's right cusp, and severe paravalvular leak of the Sapien valve, due to posterior migration towards the left atrium. These were managed successfully with emergency valve-in-valve implantation using the 'double chimney' technique for the bioprosthetic aortic valve, as well as transeptal valve-in-valve implantation of a 2nd Sapien valve in the mitral valve, which sealed the gap between the 1st Sapien and the calcified mitral annulus. Discussion: This case illustrates a less invasive approach for the management of severe MAC. Complications can still occur in this high-risk group of patients, and therefore, such cases should be managed with close collaboration between cardiac surgeons and cardiologists, in centres with high expertise.

Transcatheter Valve Repair in Heart Failure with Moderate to Severe Mitral Regurgitation.

BACKGROUND: Whether transcatheter mitral-valve repair improves outcomes in patients with heart failure and functional mitral regurgitation is uncertain. METHODS: We conducted a randomized, controlled trial involving patients with heart failure and moderate to severe functional mitral regurgitation from 30 sites in nine countries. The patients were assigned in a 1:1 ratio to either transcatheter mitral-valve repair and guideline-recommended medical therapy (device group) or medical therapy alone (control group). The three primary end points were the rate of the composite of first or recurrent hospitalization for heart failure or cardiovascular death during 24 months; the rate of first or recurrent hospitalization for heart failure during 24 months; and the change from baseline to 12 months in the score on the Kansas City Cardiomyopathy Questionnaire-Overall Summary (KCCQ-OS; scores range from 0 to 100, with higher scores indicating better health status). RESULTS: A total of 505 patients underwent randomization: 250 were assigned to the device group and 255 to the control group. At 24 months, the rate of first or recurrent hospitalization for heart failure or cardiovascular death was 37.0 events per 100 patient-years in the device group and 58.9 events per 100 patient-years in the control group (rate ratio, 0.64; 95% confidence interval [CI], 0.48 to 0.85; P = 0.002). The rate of first or recurrent hospitalization for heart failure was 26.9 events per 100 patient-years in the device group and 46.6 events per 100 patient-years in the control group (rate ratio, 0.59; 95% CI, 0.42 to 0.82; P = 0.002). The KCCQ-OS score increased by a mean (±SD) of 21.6±26.9 points in the device group and 8.0±24.5 points in the control group (mean difference, 10.9 points; 95% CI, 6.8 to 15.0; P<0.001). Device-specific safety events occurred in 4 patients (1.6%). CONCLUSIONS: Among patients with heart failure with moderate to severe functional mitral regurgitation who received medical therapy, the addition of transcatheter mitral-valve repair led to a lower rate of first or recurrent hospitalization for heart failure or cardiovascular death and a lower rate of first or recurrent hospitalization for heart failure at 24 months and better health status at 12 months than medical therapy alone. (Funded by Abbott Laboratories; RESHAPE-HF2 ClinicalTrials.gov number, NCT02444338.).

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.

Clinical Outcomes of Left Main Coronary Artery PCI With Rotational Atherectomy.

Data regarding rotational atherectomy percutaneous coronary intervention (RA PCI) angioplasty in the left main (LM) coronary artery are scarce, and mostly outdated. We aimed to describe clinical outcomes of RA PCI in LM. Patients requiring RA in 8 European countries and 19 centers were prospectively and consecutively included in the European registry of Cardiac Care of Calcified and Complex patients registry. In-hospital data collection and 1-year follow-up were performed for each patient. Between October 2016 and July 2018, 966 patients with complete data were included. Among them, 241 presented with an LM lesion, and 171 required an LM lesion preparation by RA. The latter, allocated to the LM-RA group, were compared with the 725 patients in the non-LM-RA group. Clinical success of the RA procedure was comparable in both groups, but in-hospital major adverse cardiac events were higher in the RA-LM group (7.6% vs 3.2%, adjusted p = 0.04), mainly driven by a higher in-hospital mortality rate (5.3 vs 0.3%, adjusted p = 0.005). At 1-year follow-up, mortality and major adverse cardiac event rates were comparable in both groups (12.9% vs 8.0%, adjusted p value: 0.821, and 15.8% vs 10.9%, adjusted p value: 0.329, respectively), but the rate of target vessel revascularization remained higher in the RA-LM group (5.3% vs 3.2%, adjusted p = 0.021). In conclusion, RA PCI is an efficient option for calcified LM lesions, providing acceptable outcomes regarding this population with high risk at 1 year, and yields comparable outcomes with RA PCI performed on non-LM lesions.

P-Wave Beat-to-Beat Analysis to Predict Atrial Fibrillation Recurrence after Catheter Ablation.

The identification of patients prone to atrial fibrillation (AF) relapse after catheter ablation is essential for better patient selection and risk stratification. The current prospective cohort study aims to validate a novel P-wave index based on beat-to-beat (B2B) P-wave morphological and wavelet analysis designed to detect patients with low burden AF as a predictor of AF recurrence within a year after successful catheter ablation. From a total of 138 consecutive patients scheduled for AF ablation, 12-lead ECG and 10 min vectorcardiogram (VCG) recordings were obtained. Univariate analysis revealed that patients with higher B2B P-wave index had a two-fold risk for AF recurrence (HR: 2.35, 95% CI: 1.24-4.44, p: 0.010), along with prolonged P-wave, interatrial block, early AF recurrence, female gender, heart failure history, previous stroke, and CHA2DS2-VASc score. Multivariate analysis of assessable predictors before ablation revealed that B2B P-wave index, along with heart failure history and a history of previous stroke or transient ischemic attack, are independent predicting factors of atrial fibrillation recurrence. Further studies are needed to assess the predictive value of the B2B index with greater accuracy and evaluate a possible relationship with atrial substrate analysis.

Effect of Sex on Outcomes of Coronary Rotational Atherectomy Percutaneous Coronary Intervention (From the European Multicenter Euro4C Registry).

Data regarding the potential influence of gender on outcomes of rotational atherectomy (RA) percutaneous coronary intervention (PCI) are scarce and conflicting. Using the Euro4C registry, an international prospective multicentric registry of RA PCI, we evaluated the influence of gender on clinical outcomes of RA PCI. Between October 2016 and July 2018, 966 patients were included. In them, 267 (27.6%) were females. Female patients were older than males (77.7 years old ± 9.8 vs 73.3 ± 9.5 years old respectively, p < 0.001) had a poorer renal function (43,1% of females had a GFR < 60 ml/min:1.73m² vs 30.4% of males, p < 0.001) and were more frequently admitted for an acute coronary syndrome (32.2% vs 22.3% p = 0.002). During RA procedure, women were less likely to be treated by radial approach (65.0% vs 74.4%, p = 0.004). In-hospital major adverse cardiac event rate-defined as cardiovascular death, myocardial infarction, stroke/transient ischemic attack, target lesion revascularization, and coronary artery bypass grafting surgery-was higher in the female group (7.1% vs 3.7%, p = 0.043). However, coronary perforation, dissection, slow/low flow and tamponade did not significantly differ in gender, neither did cardiovascular medications at discharge. At 1 year follow-up, rate of major adverse cardiac event was 18.4% in the female group vs 11.2% in the male group (adjusted Hazard Ratio 1.82 [1.24 to 2.67], p = 0.002). No significant bleeding differences were observed in gender, neither in hospital, nor during follow-up. In conclusion women had worse clinical outcomes following RA PCI during hospitalization and at 1 year follow-up than did men.

Simultaneous implantation of MitraClip devices in a patient with severe mitral and tricuspid valve regurgitation.

We present a case of an 84-year old patient with severe mitral and tricuspid regurgitation with a lot of cormobidities who underwent a simultaneous transfemoral (one approach) mitral and tricuspid valve repair using the MitraClip system.

The TRACE registry (Trans-Radial Approach in Central and northErn Greece).

OBJECTIVE: We examined trans-radial approach (TRA) use in coronary angiographies (CAs) as well as in percutaneous coronary interventions (PCIs) in specific regions of Greece, its distribution in public and private catheterization laboratories (CLs) and its preference by operators. Reliable data regarding the use of TRA are not available in Greece. METHODS: The study was performed in northern and central Greece, which constitutes 35.32% of the national population. This study focused on the years 2004, 2009 and 2013. RESULTS: There are 12 CLs. CAs performed using TRA were 0.43% in 2004, 12.28% in 2009 and 39.81% in 2013, whereas PCIs performed using TRA were 0.38%, 9.20% and 39.48%, respectively. Operators familiar with TRA, but who performed TRA electively, were 13.33% in 2004, 60.38% in 2009 and 42.37% in 2013. However, operators performing TRA routinely were 2.2%, 5.66%, and 49.15%, respectively. In 2013, there was a 3.76% decrease in CAs and 4.51% decrease in PCIs compared to 2009; in private CLs, there was a 29.63% decrease in CAs and 34.72% decrease in PCIs performed, which was contradictory to the 27.27% increase observed in CAs and 29.83% increase in PCIs in public CLs. CONCLUSIONS: This is the first study to reveal the volumes and trends in interventions performed via TRA across central and northern Greece. TRA has gained a reputation among operators in both public and private CLs. Due to the financial crisis in Greece, catheterizations have been diminished, whereas private CLs have lost a great amount of their turnover.

Surgical septal myectomy for hypertrophic cardiomyopathy in Greece: a single-center initial experience.

INTRODUCTION: Surgical septal myectomy is thought to be the gold standard of treatment for obstructive hypertrophic cardiomyopathy (HCM) with obstruction symptoms refractory to optimal medical therapy. In Europe, during the last 2 decades, myectomy has been set aside, while alcohol septal ablation has been widely promoted. In this paper, we analyze our first experience of surgical septal myectomy in a small cohort of patients with HCM coming from a single tertiary center. METHODS: Thirty-two patients (16 male, 50%) with a mean age of 58.1 ± 14.4 (range 12-79 years) underwent myectomy for HCM symptoms refractory to negative inotropic agents. The technique used for the myectomy was the one introduced by Andrew Morrow. Mean follow-up time after procedure was 16.8 ± 13.3 months with a median of 13 months (range 4-58 months). RESULTS: Post-myectomy, there was a significant improvement in patients' NYHA class (from 3.3 ± 0.46 to 1.38 ± 0.49, p<0.0005), while interventricular septum thickness was reduced from 2.3 ± 0.4 cm to 1.6 ± 0.4 cm (p<0.0005), and peak gradient at the site of obstruction from 94.9 ± 29 to 16.7 ± 7.9 mmHg (p<0.0005). During the follow-up period, only 1 out of 32 patients died, from non-cardiovascular causes, with the overall survival post-myectomy being 97.2% (95%CI: 94.5-99.9%) at 1-year follow up. CONCLUSIONS: Surgical septal myectomy in patients with HCM and drug-refractory symptoms is a safe procedure that greatly improves symptoms and quality of life. Further follow-up of our patients is mandatory in order to determine whether the good survival rate achieved at 1 year will persist.

The use of rotational atherectomy and drug-eluting stents in the treatment of heavily calcified coronary lesions.

INTRODUCTION: The treatment of calcified coronary artery lesions is a challenge for percutaneous angioplasty. Rotational atherectomy is an established technique for the effective modification of these lesions prior to conventional angioplasty and stent implantation. Drug-eluting stents (DES) have shown encouraging results in complex lesions and high-risk patients. METHODS: This retrospective study investigated the immediate and long-term prognosis after treatment with rotational atherectomy (RotA) and DES implantation in 184 patients with calcified coronary artery lesions. RESULTS: During follow up (mean 49 months), 7 patients died (1 from a non-cardiac cause) and the incidence of major adverse cardiac events was 14.85%. Only 4.15% of patients underwent a new angioplasty procedure. CONCLUSIONS: The combination of RotA and DES in calcified coronary artery lesions has a very good angiographic result and a satisfactory clinical outcome.

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.

Feasibility study of a temporary percutaneous left ventricular assist device in cardiac surgery.

BACKGROUND: The aim of this study is to evaluate a percutaneous left ventricular assist device (Tandem Heart pVAD; Cardiac Assist, Pittsburgh, Pennsylvania) in the postcardiotomy setting. METHODS: Between August 2001 and August 2004, 11 high-risk male patients who had undergone heart failure surgery or surgical revascularization were supported by the TandemHeart postcardiotomy. The major indication for pVAD insertion was failure to wean from cardiopulmonary bypass. Three different techniques were employed for cannulation: the closed percutaneous technique, the "open transeptal" technique with percutaneous cannulas insertion, and direct central cannulation. RESULTS: The mean duration of support was 88 hours. The mean pump flow was 3.09 L/min. The weaning rate was 72.72%. Survival to discharge and at 1 and 4 years was 54.54%, 45.45%, and 36.36%, respectively. The main complication was pericardial bleeding, noted mainly in patients receiving antiplatelet treatment preoperatively. CONCLUSIONS: The TandemHeart appears to be safe for temporary support after cardiotomy. It is a versatile device allowing different techniques of insertion. Device application yielded high weaning rate and satisfactory early and long-term survival.

Modified (Valsalva graft) aortic root reimplantation for successful repair of pulmonary autograft aneurysm after Ross procedure.

Dilatation of the pulmonary autograft after the Ross procedure is a possible complication, necessitating aortic valve replacement. We present a case of a patient who developed pulmonary autograft dilatation and was treated successfully with valve-sparing aortic root reimplantation with a Valsalva graft.