Transcatheter tricuspid valve repair: early experience in the Netherlands.

BACKGROUND: Symptomatic tricuspid regurgitation (TR) is increasingly prevalent and impairs quality of life and survival, despite medical treatment. Transcatheter tricuspid valve repair (TTVR) has recently become available as a treatment option for patients not eligible for tricuspid valve surgery. In this study we describe the early experience with TTVR in the Netherlands. METHODS: All consecutive patients scheduled for TTVR in two tertiary hospitals were included in the current study. Patients were symptomatic and had severe functional TR. TTVR was performed either with the MitraClip (off-label use) or dedicated TriClip delivery system and device. Procedural success was defined as achievement of clip implantation, TR reduction ≥ 1 grade and no need for re-do surgical or transcatheter intervention. Clinical improvement was evaluated after 4 weeks. RESULTS: Twenty-one patients (median age 78 years, 33% male, 95% New York Heart Association class ≥ 3, 100% history of atrial fibrillation) underwent TTVR. Procedural success was achieved in 16 patients, of whom 15 reported symptomatic improvement (New York Heart Association class 1 or 2). There was no in-hospital mortality and no major complications occurred. Baseline glomerular filtration rate and TR coaptation gap size were associated with procedural success. CONCLUSION: The current study showed that TTVR seems a promising treatment option for patients with severe functional TR deemed high risk for surgery. Successful TR reduction is most likely in patients with limited coaptation gap size and strongly determines clinical benefit. Adequate patient selection and timing of treatment seem essential for an optimal patient outcome.

Veno-arterial extracorporeal membrane oxygenation in addition to primary PCI in patients presenting with ST-elevation myocardial infarction.

INTRODUCTION: Primary percutaneous coronary intervention (pPCI) in ST-elevation myocardial infarction (STEMI) can cause great haemodynamic instability. Veno-arterial extracorporeal membrane oxygenation (VA-ECMO) can provide haemodynamic support in patients with STEMI but data on outcome and complications are scarce. METHODS: An in-hospital registry was conducted enrolling all patients receiving VA-ECMO. Patients were analysed for medical history, mortality, neurological outcome, complications and coronary artery disease. RESULTS: Between 2011 and 2016, 12 patients underwent pPCI for STEMI and received VA-ECMO for haemodynamic support. The majority of the patients were male (10/12) with a median age of 63 (47-75) years and 4 of the 12 patients had a history of coronary artery disease. A cardiac arrest was witnessed in 11 patients. The left coronary artery was compromised in 8 patients and 4 had right coronary artery disease. All patients were in Killip class IV. Survival to discharge was 67% (8/12), 1­year survival was 42% (5/12), 2 patients have not yet reached the 1­year survival point but are still alive and 1 patient died within a year after discharge. All-cause mortality was 42% (5/12) of which mortality on ECMO was 33% (4/12). Patient-related complications occurred in 6 of the 12 patients: 1 patient suffered major neurological impairment, 2 patients suffered haemorrhage at the cannula site, 2 patients had limb ischaemia and 1 patient had a haemorrhage elsewhere. There were no VA-ECMO hardware malfunctions. CONCLUSION: VA-ECMO in pPCI for STEMI has a high survival rate and neurological outcome is good, even when the patient is admitted with a cardiac arrest.

The predictive value of conventional surgical risk scores for periprocedural mortality in percutaneous mitral valve repair.

BACKGROUND: Surgical risk scores are used to identify high-risk patients for surgical mitral valve repair. There is no scoring system to estimate the mortality risk for patients undergoing percutaneous treatment. The aim of this analysis is to evaluate the predictive value of the EuroSCOREs and the Society of Thoracic Surgeons Predicted Risk of Mortality Score (STS) for periprocedural mortality in percutaneous edge-to-edge mitral valve repair. METHODS: From 2009 to 2013, 136 high-risk patients were included who underwent 143 procedures. Observed periprocedural mortality was compared with predicted mortality using the logistic EuroSCORE, EuroSCORE II and STS. The predictive value was analysed by receiver operating characteristic curves for each score. RESULTS: Observed periprocedural mortality was 3.5 %. The predicted surgical mortality risk was: 23.1 ± 15.7 % for the logistic EuroSCORE, 9.6 ± 7.7 % for the EuroSCORE II and 13.2 ± 8.2 % for the STS. The predictive value estimated by the area under the curve was: 0.55, 0.54 and 0.65 for the logistic EuroSCORE, EuroSCORE II and STS respectively. Severe pulmonary hypertension and acute procedural success were significant predictive parameters in univariate analysis. CONCLUSION: Contemporary surgical scores do not adequately predict periprocedural mortality for high-risk patients undergoing edge-to-edge mitral valve repair, but they can be used to help decision-making in the selection process for this procedure.

High-sensitive cardiac troponin T measurements in prediction of non-cardiac complications after major abdominal surgery.

BACKGROUND: Postoperative non-cardiac complication rates are as high as 11-28% after high-risk abdominal procedures. Emerging evidence indicates that postoperative cardiac troponin T elevations are associated with adverse outcome in non-cardiac surgery. The aim of this study was to determine the relationship between postoperative high-sensitive cardiac troponin T elevations and non-cardiac complications in patients after major abdominal surgery. METHODS: This prospective observational single-centre cohort study included patients at risk for coronary artery disease undergoing elective major abdominal surgery. Cardiac troponin was measured before surgery and at day 1, 3, and 7. Multivariable logistic regression analysis was performed to examine the adjusted association for different cut-off concentrations of postoperative myocardial injury and non-cardiac outcome. RESULTS: In 203 patients, 690 high-sensitive cardiac troponin T measurements were performed. Fifty-three patients (26%) had a non-cardiac complication within 30 days after surgery. Hospital mortality was 4% (8/203). An increase in cardiac troponin T concentration ≥100% compared with baseline was a superior independent predictor of non-cardiac postoperative clinical complications (adjusted odds ratio 4.3, 95% confidence interval 1.8-10.1, P<0.001) and was associated with increased length of stay (9 days, 95% confidence interval 7-11 vs 7 days, 95% confidence interval 6-8, P=0.004) and increased hospital mortality (12 vs 2%, P=0.028). CONCLUSIONS: A postoperative high-sensitive cardiac troponin T increase ≥100% is a strong predictor of non-cardiac 30 day complications, increased hospital stay and hospital mortality in patients undergoing major abdominal surgery. CLINICALTRIALSGOV IDENTIFIER: NCT02150486.

TIDES-ACS Trial: comparison of titanium-nitride-oxide coated bio-active-stent to the drug (everolimus)-eluting stent in acute coronary syndrome. Study design and objectives.

Drug-eluting stents (DES), delivering antiproliferative drugs from a durable polymer, have shown to reduce in-stent restenosis after percutaneous coronary intervention (PCI) compared to bare-metal stents (BMS). However, they have been associated with a hypersensitivity reaction, delayed healing, and incomplete endothelialization, which may contribute to an increased risk of late stent thrombosis. Consequently, a prolonged duration of dual antiplatelet therapy (DAPT) is needed, with an increased risk of bleeding complication. A number of stent technologies are being developed in an attempt to modify late thrombotic events and DAPT duration. The Optimax™ stent is such a novel, next generation bioactive stent (BAS), in which a thicker layer of titanium-nitride-oxide coating is inserted over the stent struts. The rationale of this is to obtain more efficient and rapid vascular healing at the site of the stent implantation. The aim of TIDES-ACS Trial is to compare clinical outcome in patients presenting with ACS, treated with PCI using Optimax-BAS versus Synergy™-EES. Second objective is to explore whether the Optimax™-BAS use is superior compared with Synergy™-EES use with respect of hard end points (cardiac death, myocardial infarction [MI] and major bleeding). A prospective, randomized, multicenter trial (ClinicalTrials.gov Identifier: NCT02049229), will be conducted in interventional centres in Finland (six centres), France (five centres) and Holland (two centres), including a total of 1800 patients.

Complications during percutaneous edge-to-edge mitral valve repair.

Transcatheter edge-to-edge mitral valve repair is an approach for treating mitral regurgitation, which is an alternative for surgery in patients with a high surgical risk. Although the safety and efficacy of the technique have been demonstrated, it is still associated with potentially life-threatening complications. The aim of this paper is to discuss the nature, management, and prevention of the most important procedural complications associated with this procedure.

Percutaneous mitral valve repair using the edge-to-edge technique in a high-risk population.

Background. Percutaneous mitral valve (MV) repair using the edge-to-edge clip technique might be an alternative for patients with significant mitral regurgitation (MR) and an unacceptably high risk for operative repair or replacement. We report the short-term safety and efficacy of this new technique in a high-risk population.Methods. All consecutive high-risk patients who underwent percutaneous MV repair with the Mitraclip(®) between January and August 2009 were included. All complications related to the procedure were reported. Transthoracic echocardiography for MR grading and right ventricular systolic pressure (RVSP) measurement were performed before, and at three and 30 days after the procedure. Differences in NYHA functional class and quality of life (QoL) index were reported. Results. Nine patients were enrolled (78% male, age 75.9±9.0 years, logistic EuroSCORE 33.8±9.0%). One patient developed inguinal bleeding. In one patient partial clip detachment occurred, a second clip was placed successfully. The MR grade before repair was ≥3 in 100%, one month after repair a reduction in MR grade to ≤2 was present in 78% (p=0.001). RVSP decreased from 43.9±12.1 to 31.6±11.7 mmHg (p=0.009), NYHA functional class improved from median 3 (range 3 to 4) to 2 (range 1 to 4) (p=0.04), and QoL index improved from 62.9±16.3 to 49.9±30.7 (p=0.12). Conclusion. In high-risk patients, transcatheter MV repair seems to be safe and a reduction in MR can be achieved in most patients, resulting in a short-term improvement of functional capacity and QoL. (Neth Heart J 2010;18:437-43.).

Three-dimensional transoesophageal echocardiography in a patient undergoing percutaneous mitral valve repair using the edge-to-edge clip technique.

We report a case of percutaneous mitral valve repair, using the Mitraclip device, in which we show that application of real-time three-dimensional transoesophageal echocardiography (3D-TEE) is extremely helpful for the guidance of this procedure. Because of its excellent visualization capacities, 3D-TEE simplifies the transseptal puncture, the positioning of the clip above the mitral valve orifice, the grasping of the mitral valve leaflets, and the evaluation of the final result. Therefore, we conclude that 3D-TEE has the potential to increase the safety and efficacy of this new technique to treat mitral regurgitation in patients who cannot undergo conventional valve surgery.

Vascular occlusion as a late complication of the Angio-Seal closure device. A review of literature.

Although early vascular complications of the Angio-Seal closure device have been well described, little is known about late vascular complications due to this device. The aim of this paper is to discuss late femoral stenosis associated with the use of the Angio-Seal closure device. A literature search was performed using Medline', Embase' and The Cochrane Library' to identify relevant articles published up to the first of May 2007. Late occlusion was defined as an occlusion after approximately one week after Angio-Seal deployment. All together, eleven relevant papers were available. The reported prevalence of late vascular stenosis associated with Angio-Seal use varies between 1/961 and 4/175. Claudication was the most frequently reported complaint. In most cases, late stenosis due to the use of the Angio-Seal required surgery. Vascular obstruction due to the device has been reported up to 6 months after placement. In conclusion, vascular stenosis due to the use an Angio-Seal closure device is a complication that not only occurs in the first few days after placement, but also in the following months. In every patient developing complaints of arterial insufficiency after using an Angio-Seal, local arterial stenosis due to the device should be considered in the differential diagnosis. It therefore is important to register the use of the device in the patient chart.

Rationale of the REPARATOR study: A randomised trial with serial cardiac MRI follow-up testing the ability of atorvastatin to reduce reperfusion damage after primary PCI for acute MI.

The REPARATOR study is a multicentre clinical trial in which the effect of 80 mg atorvastatin on microvascular (re)perfusion and late ventricular remodelling, and infarct size in patients presenting with an acute ST-elevation myocardial infarction is studied. Primary endpoint is end-systolic volume index at three months measured by quantitative cine magnetic resonance imaging (MRI). Secondary endpoints are cardiac MI (CMR) measurements of global and regional left ventricular function, MRI measurements of infarct size on admission, one week and three months as well as changes between MRI investigations, biochemical markers of infarct size, blush grade, and TIMI frame count. A total of 50 patients will be enrolled. Including three months follow-up, the study will last for six months.

The Octopus Study: rationale and design of two randomized trials on medical effectiveness, safety, and cost-effectiveness of bypass surgery on the beating heart.

The Octopus Study consists of two multicenter randomized clinical trials in which coronary artery bypass grafting on the beating heart (off-pump CABG) using the Utrecht Octopus Method is compared to intracoronary stent implantation and conventional CABG. The primary endpoint in the comparison of off-pump CABG versus stent implantation (OctoStent Trial) is medical effectiveness (i.e., absence of reintervention and major adverse cardiac and cerebrovascular events at 1 year after treatment). The primary endpoint in the comparison of off-pump CABG versus conventional CABG (OctoPump Trial) is cerebral safety (i.e., absence of cognitive deficits and cerebrovascular events at 3 months after treatment). Secondary endpoints in both trials include presence and severity of angina, quality of life, exercise capacity, and cost-effectiveness. A total of 560 patients will be enrolled. A random sample of 210 patients will undergo repeat angiography at 1 year to assess angiographic restenosis rate and graft patency. Including 1-year follow-up, the study will last for 3 years. Control Clin Trials 2000;21:595-609

Coronary artery disease: arterial remodelling and clinical presentation.

OBJECTIVE: To investigate the hypothesis that in coronary artery disease large plaques in compensatorily enlarged segments are associated with acute coronary syndromes, whereas smaller plaques in shrunken segments are associated with stable angina pectoris. METHODS: Patients selected for percutaneous transluminal coronary angioplasty (PTCA) were divided into two groups, one with stable angina pectoris (stable group, n = 37) and one with unstable angina or postmyocardial infarction angina of the infarct related artery (unstable group, n = 32). In both groups, remodelling at the culprit lesion site was determined by intravascular ultrasound before the intervention. Remodelling was calculated as relative vessel area: [vessel area culprit lesion site / mean vessel area of both proximal and distal reference sites] x 100%. Compensatory enlargement was defined as remodelling of >/= 105%, whereas shrinkage was defined as remodelling of

Clinical implications of online and off-line interobserver variability in intracoronary ultrasound-guided interventions.

UNLABELLED: Intracoronary ultrasound (ICUS)-guided interventions imply online decision making. We investigated the on- and off-line interobserver variability in ICUS measurements and evaluated the clinical implication of the interobserver variability for ICUS-guided interventions in 40 lesions (38 patients). On the same recorded ICUS images, an online and an off-line observer independently selected and analyzed the proximal and distal reference images, the most severe stenosis image before intervention and the minimal lumen area (MLA) image after intervention. In addition, the off-line observer analyzed the online selected images. The interobserver variability (percentage difference between the two observers) of ICUS measurements was determined on images independently selected by both observers (Analysis A) and on images selected by the online observer (Analysis B). The balloon size was determined from ICUS measurements according to the CLOUT trial. After intervention, the CLOUT and MUSIC criteria for MLA by ICUS had to be fulfilled for PTCA and stent procedures, respectively. In Analysis A, the on- and off-line interobserver variability in diameter and area measurements was maximally 9% and 18%, respectively. In Analysis B, the on- and off-line interobserver variability was maximally 6% and 11%, respectively. The off-line observer would have chosen a balloon size differing by more than 0.25 mm in 25 % (10 of 40) and 12.5% (5 of 40) of the procedures in Analysis A and B, respectively. After PTCA or stenting, the off-line observer would have taken different procedural decisions in 19% or 15% and in 13% or 7% of the procedures in Analysis A and B, respectively. IN CONCLUSION: when the same location was selected, the on- and off-line interobserver variability was low. When different locations were selected, however, the interobserver variability resulted in different balloon sizing in 25 % of the cases. Interobserver variability may be a confounding factor in the analysis of ICUS-guided interventions.

Coronary artery bypass grafting without cardiopulmonary bypass using the octopus method: results in the first one hundred patients.

OBJECTIVE: Cardiopulmonary bypass and global cardiac arrest enable safe coronary artery bypass grafting but have adverse effects. In off-pump coronary bypass grafting, invasiveness is reduced, but anastomosis suturing is jeopardized by cardiac motion. Therefore the key to successful off-pump coronary bypass grafting is effective local cardiac wall stabilization. METHODS: We prospectively assessed the safety and efficacy of the Octopus tissue stabilizer (Medtronic, Inc., Minneapolis, Minn.) in the first 100 patients selected for off-pump coronary bypass via full or limited surgical access. To immobilize and expose the coronary artery, two suction paddles (-400 mm Hg), fixed to the operating table-rail by an articulating arm, stabilized the anastomosis site. RESULTS: One hundred forty-one grafts (96% arterial) were used to create 172 anastomoses (17% side-to-side), up to 4 per patient, on average 23 in the full access group (46 patients) and 1.2 in the limited access group (54 patients). Complications included conversion to cardiopulmonary bypass (2%), conversion from limited to full access (3%), myocardial infarction (4%), predischarge coronary reintervention (2%), and late coronary reintervention (1%). Median postoperative length of hospital stay was 4 days (limited access) or 5 days (full access). Rapid recovery allowed 96% of patients to resume social activities within 1 month. At the 6-month angiographic follow-up, 95% of anastomoses was patent. At the 2- to 22-month follow-up (mean, 13 months), 98 patients were in Canadian Cardiovascular Society class I and 2 patients were in class II. CONCLUSION: These results suggest that off-pump coronary artery bypass grafting with the Octopus tissue stabilizer is safe. Early clinical outcome and patency rates warrant a randomized study comparing this methods with conventional coronary bypass grafting.

Shrinkage of human coronary arteries is an important determinant of de novo atherosclerotic luminal stenosis: an in vivo intravascular ultrasound study.

OBJECTIVE: To assess the occurrence of arterial remodelling types and its relation with the severity of luminal stenosis in atherosclerotic coronary arteries. PATIENTS AND METHODS: Twenty one de novo coronary lesions of 20 patients, who were scheduled for percutaneous transluminal coronary angioplasty (PTCA), were investigated with intravascular ultrasound before PTCA. Local arterial remodelling at the lesion site was studied by measuring the cross sectional area circumscribed by the external elastic lamina (EEL) relative to the reference site: (EEL area lesion/reference EEL area) x 100%. Three groups were defined. Group A: relative EEL area of less than 95% (shrinkage), group B: relative EEL area between 95% and 105% (no remodelling), group C: relative increase in EEL area of more than 105% (compensatory enlargement). RESULTS: All three types of remodelling were observed at the lesion site: group A (shrinkage) n = 8, group B (no remodelling) n = 5, group C (compensatory enlargement) n = 8. The mean (SD) relative EEL area at the lesion site in group A and C was 83(9)% and 132(30)%, respectively. In group A, 33% of the luminal area stenosis at the lesion site was caused by shrinkage of the artery. In contrast, group C showed that 87% of the plaque area did not contribute to luminal area stenosis because of compensatory arterial enlargement. CONCLUSIONS: These results show that both compensatory enlargement and paradoxical shrinkage occurs in the atherosclerotic coronary artery. Next to plaque accumulation, the type of atherosclerotic remodelling is an important determinant of luminal narrowing.

Remodeling of the atherosclerotic arterial wall: a determinant of luminal narrowing in human coronary arteries.

BACKGROUND: The type of remodeling of the human femoral artery (enlargement or shrinkage) is related to the percentage luminal stenosis. OBJECTIVE: To assess how local changes in vessel size, together with plaque load, determine luminal narrowing in atherosclerotic human coronary arteries. METHODS: We obtained 576 segments of 28 coronary arteries from 10 patients who had died from noncardiac causes. The lumen area and area circumscribed by the internal elastic lamina (IEL) area, a measure of local vessel size in each histologic cross-section were measured, and the mean lumen diameter and mean IEL diameter were calculated. To correct for arterial tapering, expected reference diameter values were calculated at the same location using linear regression of all data points along the artery. The IEL diameter and lumen diameter were expressed as percentages of the calculated IEL diameter and lumen diameter at the same location (percentage lumen diameter stenosis and relative IEL diameter, respectively). RESULTS: We found a negative relation between the relative IEL diameter and the percentage lumen diameter stenosis. On average, a narrower than expected lumen diameter was accompanied by a smaller than expected IEL diameter. A larger than expected lumen diameter was accompanied by a larger than expected IEL diameter. This relation was found for the left anterior descending, circumflex, and right coronary arteries (y = -0.60x + 105.33, r = 0.48; y = -0.45x + 100.69, r = 0.84; and y = -0.39x + 101.84, r = 0.61, respectively, all P < 0.05). CONCLUSIONS: Local luminal narrowing was correlated with a decrease in vessel size. Local remodeling of the artery is one of the determinants of luminal narrowing in the atherosclerotic human coronary artery.

Revascularization of patients with coronary artery disease: the interventional cardiologist's perspective.

In the majority of patients with chronic coronary artery disease, treatment is aimed at palliation or prolongation of disease-free intervals and consists of either pharmacologic therapy or coronary revascularization. As a result of continuous refinements and improvements in both surgical and catheter-based revascularization techniques, modalities, and adjunctive pharmacologic therapy, an increasing number of patients may benefit from coronary revascularization. This also engenders difficult choices for the physicians responsible for selecting the most appropriate treatment. To achieve and provide optimal patient care an open and principled discussion with all parties involved is mandatory and must be based on the integration of clinical experience and data from both basic and clinical research. The purpose of this article is to provide the interventional cardiologist's view on the treatment of patients with atherosclerotic coronary artery disease.

Clinical trials on intracoronary stenting.

The stent is currently taking the lead in the treatment of obstructive coronary artery disease. The interest in this device is not only reflected by the relative number of patients referred for angioplasty and treated with a stent but also by the large number of clinical trials. These can be divided into trials assessing the safety and feasibility of the implantation of second generation or new stents, studies assessing novel treatment strategies and randomized clinical trials. With respect to the latter, they all compare stent implantation with balloon angioplasty. Of major importance will be the comparison of stent implantation with surgical revascularization of obstructive coronary artery disease. The increasing number of therapeutic options, however, confront the physician with the difficult choice and responsibility of selecting the most appropriate treatment. Therefore, systematic and objective evaluation of the available therapeutic approaches by means of appropriately designed trials is imperative. The purpose of this paper is to summarize and to put into perspective the various studies on intracoronary stenting. Distinction is made between observational studies testing a device or evaluating a new concept in intracoronary stenting and randomized clinical trials.