COAPT-Like Profile Predicts Long-Term Outcomes in Patients With Secondary Mitral Regurgitation Undergoing MitraClip Implantation.

OBJECTIVES: The aim of this study was to evaluate whether fulfilling COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation) criteria identifies patients with better outcomes after MitraClip treatment for secondary mitral regurgitation (SMR). BACKGROUND: To date, COAPT is the only trial showing a prognostic benefit of MitraClip implantation compared with conservative management. METHODS: Three hundred four patients with SMR undergoing MitraClip placement in addition to optimal medical therapy at 3 European centers were analyzed. A COAPT-like profile was defined as absence of all the following criteria: severe left ventricular impairment, moderate to severe right ventricular dysfunction, severe tricuspid regurgitation, severe pulmonary hypertension, and hemodynamic instability. Freedom from all-cause death and from a composite endpoint (cardiovascular death and heart failure hospitalization) were evaluated at 2- and 5-year follow-up. RESULTS: A COAPT-like profile was observed in 65% of the population. Compared with non-COAPT-like patients, those fulfilling COAPT criteria had greater survival free from all-cause death and from the composite endpoint at both 2 year (75% vs. 55% and 67% vs. 47%; p < 0.001 for both) and 5-year (49% vs. 25% and 40% vs. 19%; p < 0.001 for both) follow-up. Among the non-COAPT-like patients, similar outcomes were observed in those fulfilling 1 or ≥1 criterion. Left ventricular impairment had a late impact on outcomes, while right ventricular impairment, pulmonary hypertension, and hemodynamic instability had early effects. COAPT-like profile was an independent predictor of long-term outcomes, as well as administration of neurohormonal antagonists, European System for Cardiac Operative Risk Evaluation II score, and previous heart failure hospitalization. CONCLUSIONS: A COAPT-like profile, including specific echocardiographic and clinical criteria, identifies patients with SMR who have a better prognosis after MitraClip implantation.

Left ventricular reverse remodelling predicts long-term outcomes in patients with functional mitral regurgitation undergoing MitraClip therapy: results from a multicentre registry.

AIMS: To explore whether left ventricular reverse remodelling (LVRR) is a predictor of outcomes in patients with functional mitral regurgitation (FMR) undergoing MitraClip procedure. METHODS AND RESULTS: We analysed 184 consecutive patients with FMR who underwent successful MitraClip procedure. LVRR was defined as a reduction in left ventricular end-systolic volume ≥ 10% from baseline to 6 months. LVRR was observed in 79 (42.9%) patients. Compared with non-LVRR, LVRR patients were more likely to be females, less likely to have an ischaemic aetiology of mitral regurgitation or a prior (<6 months) heart failure (HF) hospitalization, and had smaller left ventricular dimensions. New York Heart Association class improved from baseline up to 1-year follow-up in both groups. Higher rates of overall survival (87.3% vs. 75.2%, P = 0.039), freedom from HF hospitalization (77.2% vs. 60%, P = 0.020), and freedom from the composite endpoint (cardiovascular mortality or HF hospitalization) (74.7% vs. 55.2%; P = 0.012) were observed in LVRR vs. non-LVRR patients at 2-year follow-up. LVRR was associated with a significant reduction of the adjusted relative risk of mortality, HF hospitalization and composite endpoint [hazard ratio (HR) 0.44; 95% confidence interval (CI) 0.20-0.96, P = 0.040; HR 0.55; 95% CI 0.32-0.97, P = 0.038; and HR 0.54; 95% CI 0.32-0.92, P = 0.023, respectively]. Female gender, absence of diabetes, freedom from prior HF hospitalization, non-ischaemic aetiology of mitral regurgitation, and left ventricular end-diastolic diameter < 75 mm were found to be independent predictors of LVRR. CONCLUSIONS: Left ventricular reverse remodelling is associated with better long-term outcomes in patients with FMR successfully treated with MitraClip. A careful patient selection may be useful as specific baseline features predict favourable left ventricular remodelling. [Correction added on 17 January 2019, after online publication: the preceding sentence has been changed.].

Self-expanding transcatheter aortic valve implantation for degenerated small Mitroflow bioprosthesis: early and midterm outcomes.

AIMS: The aim of this study was to report clinical outcomes of self-expanding transcatheter aortic valve implantation (TAVI) for failed small Mitroflow (MF) bioprostheses. METHODS AND RESULTS: Between January 2013 and July 2016, 15 symptomatic patients (NYHA Class ≥III) with degenerated small MF (≤23 mm) underwent CoreValve (CV) or Evolut R (EvR) implantation due to high/prohibitive risk for surgical redo. The MF size was 19 or 21 mm (off-label in Europe) in eight patients. A "preventive" left main (LM) stenting was successfully performed in one patient. Early LM obstruction occurred in two cases requiring stenting. Late LM obstruction was observed in one subject. A significant correlation between virtual left transcatheter valve-to-coronary ostia (VTC) distance and left sinus of Valsalva (LSV) diameter was observed (R=0.652; p=0.012). However, only left VTC was significantly smaller in patients who experienced LM obstruction compared to those who did not (p=0.002). No cases of moderate/severe stenosis were observed in either on- or off-label procedures. No death or other major events occurred up to the one-year follow-up. CONCLUSIONS: CV or EvR implantation for failed small MF has favourable early and midterm outcomes if a careful risk evaluation and preventive measures for coronary obstruction are adopted. Low gradients can be achieved regardless of MF size.

Percutaneous edge-to-edge mitral valve repair for the treatment of acute mitral regurgitation complicating myocardial infarction: A single centre experience.

BACKGROUND: Limited evidence is available about MitraClip therapy in patients with acute mitral regurgitation (MR) complicating myocardial infarction (MI). METHODS AND RESULTS: Among 80 consecutive patients undergoing MitraClip treatment, 5 (6.3%) had been admitted for acute MI complicated by severe MR. Mean age was 73±6years and 3 were males. At the time of admission they were in cardiogenic shock (80%) or pulmonary oedema (20%), with severe MR, left ventricular dysfunction and pulmonary hypertension. The indication to MitraClip treatment was based on severe hemodynamic instability with dependence on intravenous therapy and mechanical supports despite percutaneous coronary revascularization and on high surgical risk of 27.1±13% and 10.2±6% using Euroscore II and STS score respectively. MitraClip procedure was performed at 53±33days from admission. One or two clips were employed in 2 and 3 patients respectively. Procedural success (MR≤2+) was achieved in all patients without complications and with successful weaning from mechanical supports and intravenous drugs in all but one patient who underwent left ventricular assist device implantation at 60days from MitraClip procedure. MR recurrence occurred at 30-day follow-up in one patient who had concomitant aortic regurgitation. One patient died during follow-up for non-cardiovascular cause. However, recovery of hemodynamic balance with significant and persistent pulmonary pressure reduction and functional status improvement up to 2-year follow-up was observed in most of the patients. CONCLUSIONS: Critical patients with acute ischemic MR post-MI with persistence of hemodynamic instability after coronary revascularization may benefit from MitraClip therapy acutely with favourable long-term follow-up results.

Mitraclip therapy in patients with functional mitral regurgitation and missing leaflet coaptation: is it still an exclusion criterion?

AIMS: The aim of this study was to investigate the feasibility, safety, and efficacy of Mitraclip therapy in patients with functional mitral regurgitation (MR) and missing leaflet coaptation (MLC). METHODS AND RESULTS: Out of 62 consecutive patients with functional MR undergoing Mitraclip implantation, 22 had MLC defined as the presence of a 'gap' between two mitral leaflets or insufficient coaptation length (<2 mm), according to the EVEREST II criterion. Compared with the control group, the MLC population had a significantly higher effective regurgitant orifice area (0.67 ± 0.31 vs. 0.41 ± 0.13 cm2 ; P = 0.019) and sphericity index (0.80 ± 0.11 vs. 0.71 ± 0.10; P = 0.003). MLC patients were treated with pharmacological/mechanical support in order to improve leaflet coaptation and to prepare the mitral valve apparatus for grasping. Implantation of >1 clip and device time were comparable in patients with and without MLC (61.9% vs. 47.5%; P = 0.284 and 101 ± 39 vs. 108 ± 69 min; P = 0.646, respectively). No significant differences were observed between the two cohorts in technical success (95.5% vs. 97.5%, P = 0.667), 30-day device success (85.7% vs. 78.9%; P = 0.525), procedural success (81.8% vs. 75%; P = 0.842), and 1-year patient success (52.9% vs. 44.1%; P = 0.261), defined according to the MVARC (Mitral Valve Academic Research Consortium) criteria. The long-term composite endpoint of cardiovascular death and heart failure hospitalization was similar in the two groups (49.9% vs. 44.4%; P = 0.348). A significant improvement of MR and NYHA functional class and a lack of reverse remodelling were observed up to 2 years in both arms. CONCLUSION: The Mitraclip procedure could be extended to patients with functional MR who do not fulfil the coaptation length EVEREST II criterion and who would otherwise be excluded from this treatment.

Chest Blunt Trauma: An Uncommon Cause of Aortic Stentless Bioprosthesis Dysfunction.

Acute leaflet rupture occurred in a Freedom Solo (Sorin Group, Milan, Italy) pericardial stentless aortic bioprosthesis after chest blunt trauma 8 years after valve replacement. Intraoperative findings revealed an acute tear of the right cusp at the level of the structural suture line. Pericardial leaflets were not degenerated at histologic analysis. Reoperation was easy, with simple removal of the prosthetic cusps, and a sutureless Perceval (Sorin Group) bioprosthesis was successfully implanted. This is the first reported case of an acute rupture of a stentless aortic bioprosthesis after a chest blunt trauma and the first histologic analysis of an 8-year-old Freedom Solo.

First-in-Man, Mitral Valve-in-Valve Transcatheter Implantation Through an Innovative Minimally Invasive Surgical Approach.

Degeneration of a surgically implanted valve bioprosthesis may occur in elderly, frail patients with an extremely high risk to undergo redo cardiac surgery. Transapical or fully percutaneous transseptal approaches have been described in order to treat degenerated aortic and mitral bioprosthesis. We performed the first-in-man successful mitral transcatheter valve delivery with a valve-in-valve technique through an innovative route; ie, a video-assisted endoscopic direct access to the left atrium, in an 82-year-old patient who previously underwent surgical replacement of the mitral valve and with a prohibitive surgical risk.

Role of different vascular approaches on transcatheter aortic valve implantation outcome: a single-center study.

OBJECTIVE: To compare different vascular approaches on clinical outcome of patients undergoing transcatheter aortic valve implantation (TAVI) with self-expandable bioprosthesis. METHODS: We included all the patients undergoing CoreValve implantation at our institute between September 2007 and March 2014. They were divided into four groups based on the vascular approach: percutaneous transfemoral (pTF), cut-down transfemoral (cTF), transaxillary (TAx) and transaortic (TAo). Clinical outcomes were evaluated according to Valve Academic Research Consortium-2 recommendations. RESULTS: Out of 322 consecutive patients, 170 (53%) underwent pTF, 76 (23%) cTF, 32 (10%) TAx and 44 (14%) TAo approach. Although the TAx and TAo patients had a higher risk profile, they had a similar outcome compared with the pTF and cTF groups; in particular, there were no differences regarding cardiovascular and all-cause mortality at 30 days, 1 and 2 years, as well as stroke, myocardial infarction, bleeding, major vascular complications, permanent pacemaker implantation and acute kidney injury rates. The observed device success rate was higher in the TAo than in the other approaches (88.6 versus 65.9, 68.7 and 76.3% in the pTF, cTF and TAx groups, respectively; P = 0.019). No differences occurred regarding 30-day early safety and 1-year clinical efficacy across the four groups. Fluoroscopy time, amount of contrast medium used and minor vascular complications were significantly higher in pTF patients, as well as in-hospital stay in the TAo group. Atrial fibrillation and prosthetic valve regurgitation, but not the vascular approach, were independent predictors of all-cause mortality. CONCLUSION: A more invasive vascular approach, for CoreValve implantation, even in higher risk patients, does not affect early-term, mid-term and long-term outcomes.

Effectiveness of MitraClip therapy in patients with refractory heart failure.

OBJECTIVES: To assess outcomes for MitraClip therapy in patients with refractory heart failure (HF) and mitral regurgitation (MR) ≥3+. BACKGROUND: The beneficial role of Mitraclip also in patients with severe HF has been reported. METHODS: Out of 45 patients undergoing MitraClip implantation at our institute, 16 were on refractory HF defined as diuretics and/or inotropics infusion and/or IABP dependence (group A) or labile haemodynamic balance (group B). RESULTS: Patients were aged 69 ± 13 years and 75% were males. Group A (8 patients) had a mean hospitalization length before MitraClip procedure of 5333 days. Group B (8 patients) had a mean rate of hospitalization, in the last 50 days before procedure, of 254 days. Acute procedural success was observed in 94% of patients. All but one patients of group A were quickly weaned from pharmacologic and/or mechanical supports within 5 ± 3 days from procedure and discharged at 20±10 days. All patients of group B were discharged after 10±8 days from MitraClip. At 1 year: a) cumulative survival rate was 78%; b) all patients were in NYHA functional class ≤ II; c) residual MR ≤ 2 was observed in 90%; d) systolic pulmonary arterial pressure was significantly reduced compared to the baseline (from 5410 to 398; p = 0,008); e) significant reduction of cumulative HF hospitalization days in the post-procedure year (10 days) compared to the pre-implantation year (280 days; p = 0.023) was observed. CONCLUSIONS: In patients with refractory HF and MR ≥3+, MitraClip implantation resulted in acute and persistent clinical benefit and net reduction of HF re-hospitalization.

Results of minimally invasive, video-assisted mitral valve repair in advanced Barlow's disease with bileaflet prolapse.

OBJECTIVES: Minimally invasive mitral valve (MV) surgery has recently gained popularity as the standard approach for MV repair, albeit there could be potential concerns about the feasibility of complex repair in the presence of extreme Barlow's disease via a minimally invasive route. METHODS: Fifty consecutive patients with advanced Barlow's disease and bileaflet prolapse underwent minimally invasive, video-assisted MV repair via a 5 cm right antero-lateral thoracotomy with peripheral cannulation and external aortic clamping. Mean age, left ventricular ejection fraction and New York Heart Association class were 53±11 years, 62±7% and 3.1±0.8, respectively. Logistic EuroSCORE (mean) was 3.1. Either Custodiol (36 patients; 72%) or crystalloid (14 patients; 28%) cardioplegia were utilized. Complete rings (CE Classic or Physio) were implanted. Chordal reimplantation was carried out by means of polytetrafluoroethylene (PTFE) chordae. RESULTS: All procedures were successfully performed with null/mild residual mitral regurgitation (MR) intraoperatively. A repair strategy of posterior leaflet resection and PTFE chordae implant (for anterior leaflet) or no-resect approach (only PTFE chordae on both leaflets) was performed in 62% (31 patients) and 38% (19 patients) of cases, respectively. Mean aortic cross-clamp and cardiopulmonary bypass times were 98±23 and 131±41 min, respectively. Hospital mortality was 0%. At a median follow-up of 761 days, 2 patients (4%) required reoperation (infective endocarditis: 1 patient; partial ring detachment: 1 patient) and valve rerepair was achieved in both. All patients are alive with a freedom from ≥2+ degree of MR of 100% at the latest echocardiographic evaluation. CONCLUSIONS: Minimally invasive approach for complex MV repair is feasible and safe and provided excellent early and mid-term results.

Direct transcatheter aortic valve implantation with self-expandable bioprosthesis: feasibility and safety.

BACKGROUND: Balloon valvuloplasty has been considered a mandatory step of the transcatheter aortic valve implantation (TAVI), although it is not without risk. The aim of this work was to evaluate the feasibility and safety of TAVI performed without pre-dilation (direct TAVI) of the stenosed aortic valve. MATERIAL AND METHODS: Between June 2012 and June 2013, 55 consecutive TAVI performed without pre-dilation at our institution using the self-expandable CoreValve prosthesis (Medtronic, Minneapolis, MN) were analyzed and compared with 45 pre-dilated TAVI performed the previous year. Inclusion criteria were a symptomatic and severe aortic stenosis. Exclusion criteria were defined as presence of pure aortic regurgitation, degenerated surgical bioprosthesis or bicuspid aortic valve and prior procedure of balloon aortic valvuloplasty performed as a bridge to TAVI. RESULTS: High-burden calcification in the device landing zone, assessed by CT scan, was found in most of the patients. The valve size implanted was similar in both groups. Device success was higher in direct TAVI (85%vs.64%,p=0.014), mostly driven by a significant lower incidence of paravalvular leak (PVL≥2;9%vs.33%,p=0.02). Safety combined end point at 30 days was similar in both groups. CONCLUSION: Compared to TAVI with pre-dilation, direct TAVI is feasible regardless of the presence of bulky calcified aortic valve and the valve size implanted. Device success was higher in direct TAVI, mostly driven by a lower incidence of paravalvular leak. Safety at 30 days was similar in two groups.

Platypnea and orthodeoxia in a patient with pulmonary embolism.

The platypnea-orthodeoxia syndrome is a rare clinical manifestation. Platypnea is defined as shortness of breath that worsens in the upright position, and orthodeoxia represents hypoxemia that aggravates in the upright position. We report a case of a patient with platypnea-orthodeoxia syndrome associated with pulmonary embolism and patent foramen ovale.

[Percutaneous treatment of valvular heart diseases]. / Il trattamento percutaneo delle valvulopatie.

Surgical valve replacement represents the treatment of choice for symptomatic and severe valvular heart disease. However, the operative risk is increased in presence of advanced age and comorbidities, therefore such patients are often not deemed suitable for surgical treatment. Recently, percutaneous valve replacement has emerged as an optional treatment for such patients, particularly for treating severe aortic stenosis and severe mitral regurgitation.

Non-obstructive membranes of the left atrial appendage.

The left atrial appendage (LAA) is a blind-ending, complex structure distinct from the body of the left atrium and is sometimes regarded as a minor extension of the atrium. However, it should routinely be analysed as part of a transoesophageal echocardiographic examination. In this study we describe the presence of a non-obstructive membrane traversing the cavity of the LAA, found incidentally on transoesophageal echocardiography.

Low cerebrovascular event rate in subjects with patent foramen ovale and different clinical presentations: results from a prospective non randomized study on a population including patients with and without patent foramen ovale closure.

BACKGROUND: There are conflicting data on the role of a patent foramen ovale (PFO) in the pathogenesis of cryptogenic stroke. The aim of this study was to evaluate the incidence of cerebrovascular events associated with PFO in a large population of patients during mid-term follow-up. METHODS AND RESULTS: We prospectively investigated 446 consecutive patients (58% female, age 50 ± 14 years) in whom PFO was detected by contrast echocardiography following cryptogenic stroke (30.5%), transient ischemic attack (TIA, 23.7%), migraine(10.5%) or evaluation for other cardiac diseases(35%). Prevalence of other clinical conditions potentially associated with cerebral embolism, such as mitral valve disease, atrial fibrillation and aortic atherosclerosis were 31%, 12.5%, 11.2%, respectively; 99 out of 446 patients (22%, group 1) underwent PFO closure, shortly after diagnosis, while 347 (78%, group 2) received only medical therapy (antiplatelet drugs and vitamin K antagonists). During 54 months (range 12-96) of average follow-up few events had been observed: one fatal stroke (1%) in group 1 and 3 nonfatal strokes (0.86%) in group 2 (not significant); there were more TIAs in group 1 than in group 2 (5, 5% versus 3, 0.86%, p=0.02): 8/12 new cerebrovascular events occurred in patients with previous cerebral ischemia and in 7/12 there were other cardioembolic sources. Kaplan-Meier survival free from cerebrovascular events showed a slightly better prognosis in unclosed PFO patients compared to closed PFO ones, statistically significant (p=0.004). CONCLUSIONS: New cerebrovascular events are rare in unselected subjects with PFO, even in those with previous cerebral ischemia and those who have not undergone PFO closure, with an event rate similar to that observed in the general population.

Giant asymptomatic left atrial myxoma.

The classic triad of myxoma clinical presentation is characterized by intracardiac obstruction, embolisms, and constitutional symptoms with fever, weight loss, or symptoms resembling connective tissue disease. Giant myxoma without symptoms are very rare. We present a case of a 30-year-old female with a giant asymptomatic myxoma in the left atrium, discovered by echocardiography. The patient was asymptomatic.

Measurement of the myocardial performance index in ambulatory patients with heart failure: correlation with other clinical and echocardiographic parameters and independent prognostic value.

BACKGROUND: Many echocardiographic parameters have been proposed for the assessment of the patients with heart failure (HF). Recently, the myocardial performance index (MPI) has been shown to be an accurate index of myocardial function. We assessed the correlation with other clinical and echocardiographic measurements and the prognostic value of MPI in patients with HF. METHODS AND RESULTS: The MPI was assessed in 112 consecutive patients with persistent symptoms of HF (II-III NYHA class), sinus rhythm, LV systolic dysfunction (defined by an ejection fraction 0.55 (median value) and medium to severe mitral regurgitation were associated with a relative risk of cardiovascular events of 18.7 (95% confidence interval [CI], 16.6-20.7; P < 0.005) and of 3.03 (95% CI, 2-4.1; P = 0.035), respectively. CONCLUSIONS: In our patients with HF, MPI was the best predictor of cardiovascular events. Mitral regurgitation was the only other variable which had an additive prognostic value at multivariate analysis.