Low-dose colchicine for the prevention of cardiovascular events after percutaneous coronary intervention: Rationale and design of the COL BE PCI trial.

INTRODUCTION: Patients with coronary artery disease (CAD) remain vulnerable to future major atherosclerotic events after revascularization, despite effective secondary prevention strategies. Inflammation plays a central role in the pathogenesis of CAD and recurrent events. To date, there is no specific anti-inflammatory medicine available with proven effective, cost-efficient, and favorable benefit-risk profile, except for colchicine. Initial studies with colchicine have sparked major interest in targeting atherosclerotic events with anti-inflammatory agents, but further studies are warranted to enforce the role of colchicine role as a major treatment pillar in CAD. Given colchicine's low cost and established acceptable long-term safety profile, confirming its efficacy through a pragmatic trial holds the potential to significantly impact the global burden of cardiovascular disease. METHODS: The COL BE PCI trial is an investigator-initiated, multicenter, double-blind, event-driven trial. It will enroll 2,770 patients with chronic or acute CAD treated with percutaneous coronary intervention (PCI) at 19 sites in Belgium, applying lenient in- and exclusion criteria and including at least 30% female participants. Patients will be randomized between 2 hours and 5 days post-PCI to receive either colchicine 0.5 mg daily or placebo on top of contemporary optimal medical therapy and without run-in period. All patients will have baseline hsCRP measurements and a Second Manifestations of Arterial Disease (SMART) risk score calculation. The primary endpoint is the time from randomization to the first occurrence of a composite endpoint consisting of all-cause death, spontaneous non-fatal myocardial infarction, non-fatal stroke, or coronary revascularization. The trial is event-driven and will continue until 566 events have been reached, providing 80% power to detect a 21 % reduction in the primary endpoint taking a premature discontinuation of 15% into account. We expect a trial duration of approximately 44 months. CONCLUSION: The COL BE PCI Trial aims to assess the effectiveness and safety of administering low-dose colchicine for the secondary prevention in patients with both chronic and acute coronary artery disease undergoing PCI. TRIAL REGISTRATION: ClinicalTrials.gov: NCT06095765.

The drug-eluting resorbable magnesium vascular scaffold in complex coronary bifurcations: insights from an in vivo multimodality imaging study.

AIMS: This acute in vivo study sought to provide insights regarding the feasibility of performing complex bifurcation stenting with Magmaris magnesium alloy bioresorbable scaffolds (Biotronik, Bulach, Switzerland). METHODS AND RESULTS: Twenty-five New Zealand White rabbits underwent stenting of non-diseased aorto-iliac bifurcations with the Magmaris using provisional (PS; n=5), culotte (n=6), modified T (n=6), or T and protrusion (TAP, n=8) stenting techniques. Angiography, optical coherence tomography and micro-computed tomography were performed. Angiographic results were good without evidence of side branch (SB) compromise. In 9/25 procedures, strut fractures were identified with minimal luminal compromise in two cases. PS opened the SB optimally without evidence of scaffold compromise. Culotte resulted in complete bifurcation coverage and good scaffold expansion; single strut fractures were present in three out of six and double fractures in one out of six procedures. Modified T and TAP resulted in complete bifurcation coverage, minimal neocarina double-strut layers and good expansion. In two out of six modified T procedures, strut fractures were present with SB scaffold deformity present in an additional two out of six procedures. In three out of eight TAP procedures, strut fractures were present without compromising overall scaffold integrity. CONCLUSIONS: Bifurcation stenting using Magmaris appears feasible. PS with additional TAP whenever needed seems a reasonable approach. Whenever a two-stent technique is planned, TAP appears most favourable whilst modified T and culotte stenting should probably be avoided.

Circumflex coronary artery injury after mitral valve surgery: A report of four cases and comprehensive review of the literature.

As the LCx is closely related to the mitral valve annulus, it is susceptible to perioperative injury. Various underlying mechanisms, predisposing factors, and therapeutic strategies have been suggested but disagreement exists. Using a MeSH terms-based PubMed search, 44 cases of mitral valve surgery-related LCx injury were detected, including our 4 cases. We provide a comprehensive review of current knowledge regarding mitral valve surgery-related left circumflex coronary artery (LCx) injury. Preoperative coronary angiography was performed in 55% (n = 24). Coronary abnormalities were present in 11% (n = 5). Coronary dominance was reported in 73% (n = 32), predominantly showing left (69%, n = 22) or balanced (19%, n = 6) circulations. Right coronary dominance was present in 12% (n = 4). Ischemia was detected in the perioperative or early postoperative phase in 86% (n = 30). Delayed symptoms were present in 14% (n = 5). Echocardiography demonstrated new regional wall motion abnormalities in 80% (n = 24), but was negative in 20% (n = 6) despite coronary compromise. Electrocardiography showed myocardial ischemia in 97% (n = 34), including regional ST-segment elevations in 68% (n = 23). Primary treatment was surgical in 42% (n = 15) and percutaneous in 58% (n = 21), reporting success ratios of 87% (n = 13) and 81% (n = 17), respectively. We confirm an augmented risk of mitral valve surgery-related LCx injury in balanced or left-dominant coronary circulations. Preoperative knowledge of coronary anatomy does not preclude LCx injury. An anomalous LCx arising from the right coronary cusp was identified as a possible specific high-risk entity. Electrocardiographic monitoring and intraoperative echocardiography remain paramount to ensure a timely diagnosis and treatment. © 2016 Wiley Periodicals, Inc.

Aortic Regurgitation after TAVR: From Bad to Worse.

Transcatheter aortic valve replacement (TAVR) is a valuable alternative in surgical high-risk patients with symptomatic aortic valve stenosis. Here, the case is presented of very early transcatheter heart valve degeneration, probably caused by a 'Venturi effect' of a severe paravalvular regurgitant jet. This ultimately led to a leaflet being in the open position, creating severe valvular regurgitation that necessitated classical surgical revision. The occurrence of paravalvular regurgitation, and its known relationship with an adverse prognosis after TAVR, demonstrates the clear need for innovative alterations in valve design to prevent this complication. Video 1: Angiography immediately after implantation of an Edwards SAPIEN 23 mm transcatheter heart valve, showing severe paravalvular aortic valve regurgitation. The implantation position is rather low. Video 2: Transesophageal echocardiography with 2-D color imaging showing aortic valve long-axis view at 131°, three days after implantation of an Edwards SAPIEN 23 mm transcatheter heart valve. Severe eccentric paravalvular aortic valve regurgitation is shown without a significant valvular component. The implantation position is rather low. Video 3: Transesophageal echocardiography with 2-D color imaging showing aortic valve long-axis view at 120°, one month after implantation of an Edwards SAPIEN 23 mm transcatheter heart valve. Severe combined valvular and paravalvular aortic valve regurgitation (grade 4/4) is shown.

Absorb Bioresorbable Vascular Scaffold in Complex Coronary Bifurcation Interventions: Insights From an In Vivo Multimodality Imaging Study.

BACKGROUND: Although bioresorbable scaffolds offer potential advantages compared with metallic drug-eluting stents in the treatment of complex coronary bifurcation lesions, there are concerns that the polymeric scaffold integrity may be compromised. This in vivo study sought to provide insights about the feasibility of performing complex bifurcation stenting with Absorb bioresorbable vascular scaffolds (Abbott Vascular, Santa Clara, CA). METHODS AND RESULTS: Twenty New Zealand white rabbits underwent stenting of the nondiseased aortoiliac bifurcation with bioresorbable vascular scaffolds using provisional (PS, n=5), culotte (n=5), modified-T (n=5), or T-and protrusion (n=5) stenting techniques. Angiography, optical coherence tomography, and microcomputed tomography were performed. Angiographic results were excellent without evidence of dissection or side branch (SB) compromise. PS optimally opened the SB ostium without deforming the main vessel (MV) bioresorbable vascular scaffolds, avoiding malapposition, and revealing a single connector fracture in 1 of 5 cases on microcomputed tomography. Culotte stenting resulted in complete bifurcation coverage with extensive segments of double-layered struts and inappropriately apposed struts at the bifurcation level in 3 of 5 cases. On microcomputed tomography, there was MV and SB scaffold distortion at the bifurcation with single strut fractures in 4 of 5 and double fractures in 1 of 5. Modified-T and T-and protrusion resulted in complete bifurcation coverage and in minimal double-strut layers at the neocarina. On microcomputed tomography, no strut fractures were present after modified-T, whereas in 3 of 5 T-and protrusion procedures single strut fractures were noted. CONCLUSIONS: Bifurcation stenting using bioresorbable vascular scaffolds is feasible with excellent angiographic results. PS with additional T-and protrusion whenever needed seems a reasonable approach. Whenever a 2-stent technique is planned, modified T-stenting appears the most promising.

Functional performance and quality of life in high-risk comorbid patients undergoing transcatheter aortic valve implantation for symptomatic aortic valve stenosis.

AIMS: We assessed the impact of transcatheter aortic valve implantation (TAVI) on functional performance and quality of life (QoL) in a high-risk patient population with multiple comorbidities. METHODS AND RESULTS: Between January 2009 and December 2014, 145 high-risk patients (EuroSCORE II 7.3% [4.9; 14.9]) with severe symptomatic aortic valve stenosis (AS) underwent TAVI in a single centre. We prospectively evaluated New York Heart Association (NYHA) functional class, 6-minute walking distance (6MWD), and QoL using the validated Dutch version of the EuroQol-5D (EQ-5D) descriptive assessment and a visual analogue scale (EQ-VAS) at baseline, 30 days, as well as 6, 12, and 24 months after TAVI. All patients were eligible for analysis. New York Heart Association functional class improved significantly at 30-day, 6-, 12-, and 24-month follow-up (P < 0.001 for all). The absolute 6MWD improved significantly at 30 days (+19.3 ± 8.2 m; P= 0.0499) and at 6 months (+23.3 ± 8.1 m; P = 0.0194). A favourable trend was maintained at 12 months (+17.1 ± 8.8 m; P = 0.1879), whereas at 24 months 6MWD was similar to baseline values. No significant change in the descriptive assessment of QoL (EQ5D) was observed, whereas the EQ-VAS showed a significant improvement in QoL up to 24 months (P < 0.0180 for all time-points). CONCLUSION: In high-risk comorbid patients with symptomatic AS, TAVI results in a significant but temporary improvement of functional performance when assessed with objective measures of 6MWD but not of EQ-5D. Moreover, TAVI has a significant and sustained impact on subjective well-being and exercise capacity assessed with the EQ-VAS and NYHA score.

Unusual stent fracture: diagnosis with optical coherence tomography.

: We report an unusual case of new-generation drug-eluting stent fracture, diagnosed and managed with aid of optical coherence tomography.

Hemosuccus pancreaticus caused by rupture of a splenic artery pseudoaneurysm complicating chronic alcoholic pancreatitis: an uncommon cause of gastrointestinal bleeding.

We present a case of a 52-year old female patient with intermittent gastrointestinal bleeding and iron deficiency anaemia. Repeated endoscopic investigation revealed no diagnosis, but contrast-enhanced computed tomography showed a splenic artery pseudo-aneurysm secondary to chronic alcoholic pancreatitis. A distal pancreatectomy and splenectomy was performed. Hemosuccus pancreaticus is an uncommon cause of gastrointestinal bleeding, most frequently associated with chronic pancreatitis. Erosion of a peripancreatic artery by a pseudocyst can cause a pseudoaneurysm and rupture occurs in up to 10% of the cases. Bleeding from a pseudocyst wall or rupture of an atherosclerotic or traumatic aneurysm is rare. Angiography, contrast-enhanced computed tomography and endoscopic findings can be diagnostic in the majority of cases. Angiographic embolization or surgery are both therapeutic options depending on underlying nonvascular pancreas related indications requiring surgery. We discuss diagnostic pitfalls and current therapeutic strategies in the management of this disease.

From therapeutic hypothermia towards targeted temperature management: a decade of evolution.

More than a decade after the first randomised controlled trials with targeted temperature management (TTM), it remains the only treatment with proven favourable effect on postanoxemic brain damage after out-of-hospital cardiac arrest. Other well-known indications include neurotrauma, subarachnoidal haemorrhage, and intracranial hypertension. When possible pitfalls are taken into consideration when implementing TTM, the side effects are manageable. After the recent TTM trials, it seems that classic TTM (32-34°C) is as effective and safe as TTM at 36°C. This supports the belief that fever prevention is one of the pivotal mechanisms that account for the success of TTM. Uncertainty remains concerning cooling method, timing, speed of cooling and rewarming. New data indicates that TTM is safe and feasible in cardiogenic shock, one of its classic contra-indications. Moreover, there are limited indications that TTM might be considered as a therapy for cardiogenic shock per se.

Aortic Annulus Rupture During TAVI: A Therapeutic Dilemma in the Inoperable Patient.

Aortic annulus rupture is a rare complication of transcatheter aortic valve implantation (TAVI), related to relative valve oversizing or eccentric calcification. A case is reported of periprocedural cardiac tamponade caused by aortic annulus rupture. Optimal management of periprocedural aortic annulus rupture and pseudoaneurysm formation in patients considered too frail for surgery should be discussed in a multidisciplinary setting.

[Therapeutic hypothermia: effects beyond neuroprotection]. / Therapeutische hypothermie: meer dan neuroprotectief.

In the past 10 years there have been major advances in the treatment of cardiac arrest by the application of therapeutic hypothermia (TH). TH is a safe treatment option, providing the physiological effects are taken into consideration and providing the potential pitfalls of application of hypothermia are avoided. TH (32-34°C) is just as safe and effective as cooling to 36°C ('near-normal temperature'). The benefit of TH is thus probably derived from the effective suppression of fever. The broad spectrum of pathophysiological mechanisms by which therapeutic hypothermia exerts its effect on organism in a hypoxic situation suggests a potential wider role for this therapy than in current daily clinical practice. Cardiogenic shock is no longer regarded as a contraindication for TH; in the past few years the safety and effectiveness of this treatment have been proven in patients with cardiogenic shock. In fact, the anti-ischaemic and positive inotropic effects of TH suggest that this treatment could be a potential treatment specifically for patients with cardiogenic shock.

Alternative treatment options in colorectal cancer patients with 5-fluorouracil- or capecitabine-induced cardiotoxicity.

Most chemotherapy regimens in colorectal cancer treatment are 5-fluorouracil (5-FU)/leucovorin or capecitabine-based. Cardiotoxicity is a less common but potentially lethal complication of 5-FU or capecitabine treatment, and some physicians might be unfamiliar with treatment alternatives. Rechallenging should be avoided because it carries a high risk of recurrence of the cardiac symptoms and prophylactic treatment is not always protective. Possible alternative treatment options to be considered are to replace the oral capecitabine or intravenous 5-FU by a 5-FU bolus regimen, by uracil-tegafur or tegafur/gimeracil/oteracil, both oral fluoropyrimidines combining a 5-FU prodrug with a dihydropyrimidine dehydrogenase (DPD) inhibitor, or by raltitrexed, a thymidilate synthase inhibitor whose metabolism is independent of DPD. Patients with advanced colorectal cancer and fluoropyrimidine-induced cardiotoxicity can be treated with other non-fluoropyrimidine related chemotherapy, either as a single agent, combined, or in combination with biological agents. In this report we discuss the different alternative treatment options.