Current Devices in Mitral Valve Replacement and Their Potential Complications.

Mitral regurgitation is one of the most prevalent valvulopathies worldwide, and its surgical treatment is not feasible in all cases. The elderly and frail with several comorbidities and left ventricular dysfunction are often managed conservatively. Percutaneous treatment (repair or replacement) of the mitral valve has emerged as a potential option for those patients who are at a high risk for surgery. Mitral valve repair with the Mitraclip device proved both increased safety and mortality reduction in patients with severe mitral regurgitation. On the other hand, in the last decade, percutaneous mitral replacement opened new frontiers in the field of cardiac structural interventions. There are few mitral devices; some are in the early phase of development and some are waiting for CE mark of approval. The evolution of these devices was more complicated compared to the aortic technology due to the native mitral valve's complexity and access. This review aims to provide an overview of the current devices, their specific features, and their potential complications.

Can TAVR Be Effectively and Safely Performed Without Intraprocedural TEE?

PURPOSE OF REVIEW: The TAVR procedure is a well-established therapy for patients with severe aortic stenosis at intermediate/high risk for surgery and a potential treatment for low-risk patients. It is much less invasive with short hospital stays and presents similar results compared with SAVR. Different "minimalist approach strategies" were proposed in order to obtain this performance. In these settings, transesophageal echocardiography (TEE) became less relevant for the TAVR procedure. The present review provides an update regarding the safety of TAVR without intraprocedural TEE. RECENT FINDINGS: Transthoracic echocardiography and fluoroscopy are the primary imaging tools during TAVR. Several studies proved that TAVR under local anesthesia without TEE is as safe as that performed under TEE guidance. However, not all patients have a proper window for TTE, and particular cases with complex anatomy can benefit from TEE support during the intervention. Intraprocedural TEE no longer plays a crucial role in the TAVR procedure, but in some instances, it remains of great help to detect and avoid complications.

A "minimalistic hybrid algorithm" in coronary chronic total occlusion revascularization: Procedural and clinical outcomes.

BACKGROUND: Percutaneous recanalization of coronary chronic total occlusions (CTOs) traditionally relies on the use of dual-access and large bore catheters, with trans-femoral approach adoption in most cases. OBJECTIVES: Aim of this manuscript is to describe the outcomes of an alternative hybrid algorithm, called "Minimalistic Hybrid Algorithm," which has the purpose to minimize the use of double access, large bore catheters, and femoral approach in order to minimize the risk of vascular complications and patient's discomfort, without compromising efficacy. METHODS: In this single-center registry, a "minimalistic" approach was attempted in consecutive patients undergoing CTO PCI between March 2016 and October 2017. Data regarding the applicability of this algorithm and the related procedural success rates were collected, together with common demographic and angiographic characteristics. RESULTS: Of the 100 CTO PCI performed in the study period, 91(91%) were successfully approached according to the novel algorithm. Mean J-CTO score of all minimalistic procedures was 1.9 ± 1.2, with 31(34%) patients presenting with J-CTO score ≥3. In 52 procedures, the approach consisted of single-catheter access, 49(94.2%) of which were trans-radial. Out of the 39 patients approached with dual-catheters, 26(69.2%) were biradial, and 8(21%) radial-femoral. Procedural success in patients approached with the minimalistic algorithm was 89%, in line with the results of large-multicenter experiences nowadays available. CONCLUSIONS: Our results show that an alternative algorithm limiting the routine use of large bore catheters and trans-femoral approach is feasible in the clinical practice and yields good procedural outcomes.

Complications Following Percutaneous Mitral Valve Repair.

Mitral valve disease affects more than 4 million people in the United States and it is the second most prevalent valvulopathy in Europe. The gold standard of treatment in these patients is surgical repair or mitral valve replacement. In the last decade, numerous transcatheter therapies have been developed to overcome the increased number of subjects with symptomatic severe mitral regurgitation and high surgical risk. The Mitraclip (Abbott Vascular, Menlo Park, CA), PASCAL (Edwards Lifesciences, Irvine, CA, USA), the Carillon™ Mitral Contour System™ (Cardiac Dimension Inc., Kirkland, WA, USA), the Mitralign™ (Mitralign, Tewksbury, Massachusetts), and the Cardioband (Edwards Lifesciences, Irvine, CA) are the principal percutaneous devices for mitral valve repair. We present an evidence-based clinical update that provides an overview of these technologies and their potential complications.

Veno arterial-extra corporal membrane oxygenation for the treatment of cardiac failure in patients with infective endocarditis.

INTRODUCTION: Surgery for infective endocarditis imposes great challenges in post-operative circulatory and pulmonary support but the role of veno-arterial extra-corporal membrane oxygenation in this respect is unclear. METHODS: All patients undergoing veno-arterial extra-corporal membrane oxygenation after infective endocarditis surgery were analysed for age, gender, medical history, microorganisms, clinical outcome, complications and surgical procedure. RESULTS: Between 2012 and 2016, 13 patients received veno-arterial extra-corporal membrane oxygenation following infective endocarditis surgery. The median age was 62 years (33-73) and 8/13 were male. Previous cardiac surgery was present in nine patients. Surgery for infective endocarditis consisted of a Bentall procedure in 10 patients, 2 of which received concomitant mitral valve surgery and 2 received concomitant coronary artery bypass graft. Valvular surgery alone was performed in three patients. Mortality on veno-arterial extra-corporal membrane oxygenation was 62% (8/13). Mortality during intensive care unit stay was 77% (10/13). Survival to discharge was 23% (3/13). One patient reached the 1 year survival point. Two patients who survived to discharge have not yet reached the 1 year survival point. Patient-related complications occurred in 54% (7/13) of patients and consisted of haemorrhage at the cannula site in four patients, leg ischaemia in one patient, haemorrhage at another site in one patient and infection of the cannula in one patient. Extra-corporal membrane oxygenation hardware-related complications occurred in one case consisting of clot formation in the oxygenator. CONCLUSION: Veno-arterial extra-corporal membrane oxygenation in post-cardiotomy patients who were operated on for infective endocarditis is feasible, but outcome is poor.

Transcatheter Tricuspid Valve Interventions: An Emerging Field.

PURPOSE OF REVIEW: This review aims to provide an updated overview and a clinical perspective on novel transcatheter tricuspid valve interventions (TTVI), highlighting potential challenges and future directions. RECENT FINDINGS: Severe tricuspid regurgitation (TR) is a predictor of mortality. However, a sizeable number of patients remain untreated until the end-stage when cardiac surgery presents a prohibitive risk. The emergent need in finding a treatment for patients with TR, deemed for surgery options, has encouraged the development of TTVI. These procedures mimic classical surgery techniques and are mainly divided in four categories: annuloplasty and coaptation devices, edge-to-edge techniques and transcatheter tricuspid valve replacement. Early studies showed promising results, but long-term follow-up data are not available. For patients with severe TR and high surgical risk, several percutaneous options are available. However, these therapies are in a growing phase and bigger studies and long term follow-up are needed to prove their efficacy.

Implementing a minimally invasive approach (combining radial approach, small guiding catheters and minimization of double access) for coronary chronic total occlusion intervention according to the hybrid algorithm: The Minimalistic Hybrid Algorithm.

Percutaneous recanalization of coronary chronic total occlusions (CTOs) traditionally relies on the use of dual access and large bore catheters, with trans-femoral approach adoption in most of the cases. Aim of this manuscript is to describe an alternative algorithm, that we called "Minimalistic Hybrid Algorithm", in order to minimize the use of double access, large bore catheters, and femoral approach thus reducing patient's discomfort and possibly procedural complications. This algorithm can be interpreted as an evolution of the classic "Hybrid Algorithm" and requires the operator to be confident with all techniques known in this conventional algorithm. Indeed, all possible techniques and approaches of the conventional hybrid approach to treat CTOs are included in a novel diagram for procedural strategy, which offers an alternative sequence of steps to limit, whenever possible, the invasiveness of the procedure. After dividing the cases in "simple" or "complex" CTO lesions according to the available complexity scores and to the "feeling", knowledge and expertise of the operator, a systematic description of the procedural steps is provided. This includes antegrade and retrograde approaches, as well as sub-intimal and intra-luminal techniques, in order to maintain the simpler single-catheter transradial strategies in the first line for the simple CTO, and the adoption of more complex, double access and transfemoral ones in the further steps. The minimalistic hybrid algorithm herein described is a possible alternative sequence of steps in the setting of CTO recanalization, with the potential of limiting the use of double access, large bore catheters, and femoral approach.

Impact of mitral valve treatment choice on mortality according to aetiology.

AIMS: Treatment strategies of high-risk patients with mitral regurgitation (MR) differ between disease based on functional and disease based on degenerative origin. In the present study, we aimed to evaluate the effect of surgical, percutaneous, or conservative treatment of MR according to MV mechanism, for high-risk patients. METHODS AND RESULTS: Survival outcomes of MitraClip, surgical, or conservative strategies were compared for 688 high-risk patients with functional MR and 275 with degenerative MR. Cox regression and propensity analyses were used to correct for differences in baseline characteristics. For functional MR, conservative treatment proved to have a higher mortality hazard when compared to MitraClip treatment (hazard ratio [HR] 1.79, 95% confidence interval [CI]: 1.34 to 2.39, p<0.001), while there was no significant difference in mortality hazard between MitraClip and surgery (HR 0.86, 95% CI: 0.54 to 1.38, p=0.541). For degenerative MR, no clear significant benefit was found when comparing MitraClip to conservative and surgical treatment. CONCLUSIONS: High-risk patients with symptomatic functional MR have reduced mortality when undergoing MitraClip intervention, compared to those receiving conservative treatment.

Survival After MitraClip Treatment Compared to Surgical and Conservative Treatment for High-Surgical-Risk Patients With Mitral Regurgitation.

BACKGROUND: Survival outcome after MitraClip treatment, compared with surgical or conservative treatment, is not well defined. We examined survival after MitraClip treatment in a large multicenter real-life setting. METHODS AND RESULTS: We retrospectively formed matched high-risk surgically and conservatively treated control cohorts to compare to a high-risk MitraClip cohort. One thousand thirty-six patients were included in 4 Dutch centers, of which 568 were treated with the MitraClip. The observed survival at 5-year follow-up in our MitraClip cohort was low (39.8%) but was comparable to our conservative cohort (40.5%). Observed 5-year survival for our surgical cohort was 76.3%. However, there were significant differences between the baseline characteristics of the 3 studied cohorts, with the MitraClip cohort having the highest comorbidity burden. After adjusting for baseline differences by using Cox regression, the MitraClip and surgical cohorts showed similar survival ratios (hazard ratio, 0.92; 95% confidence interval, 0.67-1.26; P=0.609), whereas both showed a lower mortality hazard when compared with conservative treatment (hazard ratio, 0.61; 95% confidence interval, 0.49-0.77; P<0.001 and hazard ratio, 0.56; 95% confidence interval, 0.42-0.76; P<0.001, respectively). CONCLUSIONS: This matched analysis suggests a lower mortality hazard for MitraClip intervention in a high-risk population with symptomatic mitral regurgitation when compared with conservative management alone.

First report of the use of long-tapered sirolimus-eluting coronary stent for the treatment of chronic total occlusions with the hybrid algorithm.

BACKGROUND: Coronary chronic total occlusions (CTO) usually coexist with diffusely diseased coronary segments proximal and/or distal to the CTO segment. During percutaneous treatment of CTO, multiple overlapping stents are often needed to treat these long lesions. OBJECTIVES: Aim of this study is to report the first use of long, tapered coronary sirolimus-eluting stents (SES) in this setting. METHODS AND RESULTS: This is a retrospective analysis of 100 consecutive patients undergoing CTO recanalization following the hybrid algorithm. Procedural success rate was 89% (11 failures). Among the successful cases, "conventional" drug-eluting stents(DES) were used in 40(44.9%) patients, while in 49(55%) patients long-tapered SES were attempted with a success rate of 98% (1 cross-over to regular stents). Total stent length in the long-tapered DES group was higher compared to the "conventional" stenting group (76 ± 28 mm vs 46 ± 22 mm, P < .001), with a similar total number of stent (1.6 ± 0.8 vs 1.9 ± 0.8). At quantitative coronary analysis, proximal and distal segment involvement was more extended in patients undergoing long-tapered stenting, with longer overall lesion length. No differences in periprocedural complications and clinical outcomes at a mean follow-up of 303 ± 179 days were observed. CONCLUSIONS: The use of long tapered coronary DES is technically feasible and safe for the percutaneous treatment of CTOs, especially for patients presenting with long lesions.

Increased incidence of infective endocarditis after the 2009 European Society of Cardiology guideline update: a nationwide study in the Netherlands.

Aims: After the introduction of the European Society of Cardiology (ESC) guidelines on prevention, diagnosis, and treatment of infective endocarditis (IE) in 2009, prophylaxis for patients at risk became less strict. We hypothesize that there will be a rise in IE after the introduction of the guideline update. Methods and Results: We performed a nationwide retrospective trend study using segmented regression analysis of the interrupted time series. The patient data were obtained via the national healthcare insurance database, which collects all the diagnoses nationwide. We compared the data before and after the introduction of the 2009 ESC guideline. Between 2005 and 2011, a total of 5213 patients were hospitalized with IE in the Netherlands. During this period, there was a significant increase in IE from 30.2 new cases per 1 000 000 in 2005 to 62.9 cases per 1 000 000 in 2011 (P < 0.001). In 2009, the incidence of IE increased significantly above the projected historical trend (rate ratio: 1.327, 95% CI: 1.205-1.462; P < 0.001). This coincides with the introduction of the 2009 ESC guideline. After the introduction of the ESC guideline, the streptococci-positive cultures increased significantly in the following years 2010-11 from 31.1 to 53.2% (P = 0.0031). Conclusion: This observational study shows that there has been a steady increase in the IE incidence between 2005 and 2011. After the introduction of the 2009 ESC guidelines, the incidence increased more than expected from previous historical trends. Furthermore, there was a significant increase in streptococci-related IE cases.

Mortality after percutaneous edge-to-edge mitral valve repair: a contemporary review.

Percutaneous edge-to-edge mitral valve (MV) repair is a relatively new treatment option for mitral regurgitation (MR). After the feasibility and safety having been proved in low-surgical-risk patients, the use of this procedure has shifted more to the treatment of high-risk patients. With the absence of randomized controlled trials (RCT) for this particular subgroup, observational studies try to add evidence to the safety aspect of this procedure. These also provide short- and mid-term mortality figures. Several mortality predictors have been identified, which may help the optimal selection of patients who will benefit most from this technique. In this article we provide an overview of the literature about mortality and its predictors in patients treated with the percutaneous edge-to-edge device.

Long-term survival and preprocedural predictors of mortality in high surgical risk patients undergoing percutaneous mitral valve repair.

OBJECTIVES: To evaluate long-term survival in high surgical risk patients undergoing percutaneous mitral valve repair (MVR) using the MitraClip(®) system and to identify preprocedural predictors of long-term mortality. BACKGROUND: Data for long-term survival and preprocedural predictors of mortality after percutaneous MVR in high surgical risk patients are sporadic. METHODS: From January 2009 to April 2013, 136 consecutive high surgical risk patients, with symptomatic moderate-to-severe or severe mitral regurgitation (MR), underwent percutaneous MVR using the MitraClip system. Cardiac and overall survival was determined at one and 2 years postprocedure. Univariate and multivariate analysis was performed to identify preprocedural predictors of long-term mortality. RESULTS: One year postprocedure, cardiac and overall survival was 86.7% and 84.6%, respectively and at 2 years cardiac and overall survival was 77.7% and 74.8%, respectively. In univariate analysis advanced age, lower body mass index, impaired renal function, elevated levels of log-N-terminal-pro-brain-natriuretic-peptide (log-NTproBNP), poor performance in functional tests (New York Heart Association (NYHA) class) and high logistic Euroscore (LES) and Society of Thoracic Surgeons (STS) score were identified as preprocedural predictors of long-term cardiac mortality. In multivariate analysis preoperative NYHA class III and IV, elevated levels of log-NTproBNP and advanced age predicted long-term cardiac mortality. CONCLUSIONS: Percutaneous MVR using the MitraClip system has favorable long-term survival rates in high surgical risk patients. Preprocedural NYHA functional class III and IV, elevated log-NTproBNP levels and advanced age predict higher long-term cardiac mortality and should be considered during patient selection.

Percutaneous coronary invervention versus coronary artery bypass grafting: a meta-analysis.

OBJECTIVE: To compare the effectiveness of percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) in patients with coronary artery disease. METHODS: MEDLINE, Embase, and Cochrane Central were searched, and randomized controlled trials were included. Outcomes were assessed at maximum available follow-up. RESULTS: This meta-analysis includes 31 trials with 15,004 patients. As regards death, more patients died after PCI compared with CABG across all types of patients (odds ratio [OR], 1.1; 95% confidence interval [CI], 1.0-1.3; P = .05) as well as in patients with multivessel disease (OR, 1.2; 95% CI, 1.0-1.4; P = .02) or diabetes (OR, 1.6; 95% CI, 1.2-2.1; P < .01). Myocardial infarction occurred as frequently after PCI (OR, 1.2; 95% CI, 0.9-1.5; P = .28). Repeat revascularization was more common after PCI (OR, 4.5; 95% CI, 3.5-5.8; P < .01), with a progressive decline in ORs from the pre-stent era (OR, 7.0; 95% CI, 5.1-9.7; P < .01), to the bare metal stent era (OR, 4.5; 95% CI, 3.6-5.5; P < .01), and to the drug-eluting stent era (OR, 2.5; 95% CI, 1.8-3.4; P < .01). Stroke was more common after CABG (OR, 0.7; 95% CI, 0.5-0.9; P = .01). CONCLUSIONS: Compared with PCI, CABG had a lower risk of death in multivessel disease or diabetes patients eligible for either intervention, a lower risk of repeat revascularization, but a higher risk of stroke.

Survival of transcatheter mitral valve repair compared with surgical and conservative treatment in high-surgical-risk patients.

OBJECTIVES: The goal of this study was to compare survival between transcatheter mitral valve (MV) repair using MitraClip system (Abbott Vascular, Santa Clara, California), MV-surgery, and conservative treatment in high-surgical-risk patients symptomatic with severe mitral valve regurgitation (MR). BACKGROUND: Up to 50% of patients with symptomatic severe MR are denied for surgery due to high perioperative risk. Transcatheter MV repair might be an alternative. METHODS: Consecutive patients (n = 139) treated with transcatheter MV repair were included. Comparator surgically (n = 53) and conservatively (n = 59) treated patients were identified retrospectively. Surgical risk was based on the logistic European System for Cardiac Operative Risk Evaluation (log EuroSCORE) or the presence of relevant risk factors, as judged by the heart team. RESULTS: The log EuroSCORE was higher in the transcatheter MV repair group (23.9 ± 16.1%) than in the surgically (14.2 ± 8.9%) and conservatively (18.7 ± 13.2%, p < 0.0001) treated patients. Left ventricular ejection fraction was higher in surgical patients (43.9 ± 14.4%, p = 0.003), with similar values for the transcatheter MV repair (36.8 ± 15.3%) and conservatively treated (34.5 ± 16.5%) groups. After 1 year of follow-up, the transcatheter MV repair and surgery groups showed similar survival rates (85.8% and 85.2%, respectively), whereas 67.7% of conservatively treated patients survived. The same trend was observed after the second and third years. After weighting for propensity score and controlling for risk factors, both the transcatheter MV repair (hazard ratio [HR]: 0.41, 95% confidence interval [CI]: 0.22 to 0.78, p = 0.006) and surgical (HR: 0.52, 95% CI: 0.30 to 0.88, p = 0.014) groups showed better survival than the conservatively treated group. The transcatheter MV repair and surgical groups did not differ (HR: 1.25, 95% CI: 0.72 to 2.16, p = 0.430). CONCLUSIONS: Despite a higher log EuroSCORE, high-surgical-risk patients with symptomatic severe MR treated with transcatheter MV repair show similar survival rates compared with surgically treated patients, with both displaying survival benefit compared with conservative treatment.

Early statin treatment prior to primary PCI for acute myocardial infarction: REPERATOR, a randomized placebo-controlled pilot trial.

OBJECTIVE: The aim of this pilot study was to determine whether early atorvastatin treatment will reduce left ventricle (LV) remodeling, infarct size, and improve microvascular perfusion. BACKGROUND: In animal studies, early statin therapy reduces reperfusion injury after a percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI). METHODS: Forty-two consecutive patients (82% male, mean age 61.2 ± 9.8) who underwent a primary PCI for a first ST-elevated AMI were randomized for pretreatment with atorvastatin 80 mg (n = 20) or placebo (n = 22) and continued with the same dosage daily for 1 week. All patients received atorvastatin 80 mg once daily 7 days after primary PCI. The LV function and infarct size were measured by magnetic resonance imaging within 1 day, at 1 week, and 3 months follow up. The primary endpoint was the end-systolic volume index (ESVI) at 3 months. Secondary endpoints were global LV function measurements, myocardial infarct size, biochemical cardiac markers, TIMI flow, and ST-T elevation resolution. RESULTS: ESVI 3 months after AMI was 25.1 mL/m(2) in the atorvastatin arm and 25.0 mL/m(2) in the placebo arm (P = 0.74). The differences in change from baseline to 3 months follow up in global LV function and myocardial infarct size did not differ between both treatment arms. Furthermore, biochemical markers, TIMI flow, and ST-T elevation resolution did not differ between atorvastatin and placebo arm. CONCLUSIONS: In this pilot study, pretreatment with atorvastatin in an acute myocardial infarction does not result in an improved cardiac function, microvascular perfusion, or decreased myocardial infarct size.

Percutaneous edge-to-edge mitral valve repair in high-surgical-risk patients: do we hit the target?

OBJECTIVES: This study sought to assess the feasibility and safety of percutaneous edge-to-edge mitral valve (MV) repair in patients with an unacceptably high operative risk. BACKGROUND: MV repair for mitral regurgitation (MR) can be accomplished by use of a clip that approximates the free edges of the mitral leaflets. METHODS: All patients were declined for surgery because of a high logistic EuroSCORE (>20%) or the presence of other specific surgical risk factors. Transthoracic echocardiography was performed before and 6 months after the procedure. Differences in New York Heart Association (NYHA) functional class, quality of life (QoL) using the Minnesota questionnaire, and 6-min walk test (6-MWT) distances were reported. RESULTS: Fifty-five procedures were performed in 52 patients (69.2% male, age 73.2 ± 10.1 years, logistic EuroSCORE 27.1 ± 17.0%). In 3 patients, partial clip detachment occurred; a second clip was placed successfully. One patient experienced cardiac tamponade. Two patients developed inguinal bleeding, of whom 1 needed surgery. Six patients (11.5%) died during 6-month follow-up (5 patients as a result of progressive heart failure and 1 noncardiac death). The MR grade before repair was ≥3 in 100%; after 6 months, a reduction in MR grade to ≤2 was present in 79% of the patients. Left ventricular (LV) end-diastolic diameter, LV ejection fraction, and systolic pulmonary artery pressure improved significantly. Accompanied improvements in NYHA functional class, QoL index, 6-MWT distances, and log N-terminal pro-B-type natriuretic peptide were observed. CONCLUSIONS: In a high-risk population, MR reduction can be achieved by percutaneous edge-to-edge valve repair, resulting in LV remodeling with improvement of functional capacity after 6 months.