Routine Protamine Administration for Bleeding in Transcatheter Aortic Valve Implantation: The ACE-PROTAVI Randomized Clinical Trial.

Importance: Vascular complications after transfemoral transcatheter aortic valve implantation (TAVI) remain an important cause of procedure-related morbidity. Routine reversal of anticoagulation with protamine at the conclusion of transfemoral TAVI could reduce complications, but data remain scarce. Objective: To evaluate the efficacy and safety of routine protamine administration after transfemoral TAVI. Design, Setting, and Participants: The ACE-PROTAVI trial was an investigator-initiated, double-blind, placebo-controlled randomized clinical trial performed at 3 Australian hospitals between December 2021 and June 2023 with a 1-year follow-up period. All patients accepted for transfemoral TAVI by a multidisciplinary heart team were eligible for enrollment. Interventions: Eligible patients were randomized 1:1 between routine protamine administration and placebo. Main Outcomes and Measures: The coprimary outcomes were the rate of hemostasis success and time to hemostasis (TTH), presented as categorical variables and compared with a χ2 test or as continuous variables as mean (SD) or median (IQR), depending on distribution. The major secondary outcome was a composite of all-cause death, major and minor bleeding complications, and major and minor vascular complications after 30 days, reported in odds ratios (ORs) with 95% CIs and P values. Results: The study population consisted of 410 patients: 199 patients in the protamine group and 211 in the placebo group. The median (IQR) patient age in the protamine group was 82 (77-85) years, and 68 of 199 patients receiving protamine (34.2%) were female. The median (IQR) patient age in the placebo group was 80 (75-85) years, and 89 of 211 patients receiving the placebo (42.2%) were female. Patients receiving up-front protamine administration had a higher rate of hemostasis success (188 of 192 patients [97.9%]) than patients in the placebo group (186 of 203 patients [91.6%]; absolute risk difference, 6.3%; 95% CI, 2.0%-10.6%; P = .006); in addition, patients receiving up-front protamine had a shorter median (IQR) TTH (181 [120-420] seconds vs 279 [122-600] seconds; P = .002). Routine protamine administration resulted in a reduced risk of the composite outcome in the protamine group (10 of 192 [5.2%]) vs the placebo group (26 of 203 [12.8%]; OR, 0.37; 95% CI, 0.1-0.8; P = .01). This difference was predominantly driven by the difference in the prevalence of minor vascular complications. There were no adverse events associated with protamine use. Conclusions and Relevance: In the ACE-PROTAVI randomized clinical trial, routine administration of protamine increased the rate of hemostasis success and decreased TTH. The beneficial effect of protamine was reflected in a reduction in minor vascular complications, procedural time, and postprocedural hospital stay duration in patients receiving routine protamine compared with patients receiving placebo. Trial Registration: anzctr.org.au Identifier: ACTRN12621001261808.

Pre-hospital heparin use for ST-elevation myocardial infarction is safe and improves angiographic outcomes.

AIMS: This study aims to evaluate if pre-hospital heparin administration by paramedics is safe and improves clinical outcomes. METHODS AND RESULTS: Using the multicentre Victorian Cardiac Outcomes Registry, linked with state-wide ambulance records, we identified consecutive patients undergoing primary percutaneous coronary intervention for STEMI between January 2014 and December 2018. Information on thrombolysis in myocardial infarction (TIMI) flow at angiography was available in a subset of cases. Patients receiving pre-hospital heparin were compared to those who did not receive heparin. Findings at coronary angiography and 30-day clinical outcomes were compared between groups. Propensity-score matching was performed for risk adjustment. We identified a total of 4720 patients. Of these, 1967 patients had TIMI flow data available. Propensity-score matching in the entire cohort yielded 1373 matched pairs. In the matched cohort, there was no observed difference in 30-day mortality (no-heparin 3.5% vs. heparin 3.0%, P = 0.25), MACCE (no-heparin 7% vs. heparin 6.2%, P = 0.44), and major bleeding (no-heparin 1.9% vs. heparin 1.4%, P = 0.64) between groups. Propensity-score analysis amongst those with TIMI data produced 552 matched pairs. The proportion of cases with TIMI 0 or 1 flow in the infarct-related artery (IRA) was lower among those receiving pre-hospital heparin (66% vs. 76%, P < 0.001) compared to those who did not. CONCLUSION: In this multicentre, propensity-score matched study, the use of pre-hospital heparin by paramedics was safe and is associated with fewer occluded IRAs in patients presenting with STEMI.

COILUMICA: coil embolization of a coronary artery to pulmonary artery fistula via novel dual lumen micro catheter technique.

BACKGROUND: Management of coronary artery fistula (CAF) is based on obliterating the fistula communication between the cardiac arteries and other thoracic vessels. CASE PRESENTATION: We describe the presentation of an 85-year-old female with progressive exertional dyspnea on a background of a long standing left anterior descending diagonal to pulmonary artery fistula. We utilized neuro-interventional techniques to perform coil embolization via use of a Scepter XC dual lumen micro catheter. CONCLUSIONS: Dual lumen balloon catheters allow for super-selective artery interrogation, stability of balloon positioning, with less trauma to vessel architecture and accurate embolization. There were no complications and the patient reported improvement of symptoms on review.

"Liver or Let Die": Percutaneous PFO Closure Through Hepatic Vein Access.

A 73-year-old farmer presented with platypnoea-orthodeoxia syndrome (POS). A transoesophageal echocardiogram (TOE) disclosed a patent foramen ovale (PFO) with significant right-to-left shunt on assuming upright posture. An initial attempt at PFO closure through the femoral vein was abandoned due to a completely occluded inferior vena cava. A second attempt through the internal jugular vein was also unsuccessful due to the steep angulation between superior vena cava and septum primum flap. Because of disabling symptoms, an attempt through a hepatic vein (HV) was scheduled and performed under general anaesthesia with TOE guidance. Ultrasound-guided access through an intercostal window to a peripheral HV was performed and the position confirmed with contrast injections. The PFO was easily crossed with a glide wire which was exchanged to a stiffer guide wire. A 25mm closure device was successfully deployed across the PFO. After retrieval of the delivery system, haemostasis of the HV was attained with a contrast-guided Gelfoam (Pfizer, New York, NY, USA) injection. Unfortunately, the patient had to undergo subsequent emergency coiling to an iatrogenically injured hepatic artery branch leading to full recovery and significant clinical improvement. Subsequent echocardiography demonstrated a well-positioned device with no residual shunt. This case illustrates that percutaneous PFO closure through a HV is a feasible procedure and should be considered in anatomy that is otherwise prohibitive for conventional approach. Extra care should be taken with initial vascular access into the HV and final haemostasis of the access site.

Threading the Eye of the Needle: A Challenging Case of Iatrogenic Spiral Coronary Artery Dissection.

Catheter induced coronary dissection is an uncommon but potentially catastrophic complication of coronary angiography. We report a case of a 48-year-old female with normal coronary arteries on angiography complicated by extensive catheter induced spiral dissection. Wiring into the true lumen was a formidable challenge as a consequence of the large false lumen obliterating the true lumen. We present management strategies and in particular, highlight the important role of intravascular ultrasound (IVUS) imaging.

Urgent transcatheter closure of patent foramen ovale followed by elective right-sided valve surgery for decompensated carcinoid heart disease.

The presence of a patent foramen ovale (PFO) is associated with morbidity and mortality in patients with carcinoid heart disease (CHD). We report a 66-year-old male patient with tricuspid and pulmonary valve regurgitation secondary to CHD, who developed severe hypoxia due to a right-to-left shunt through a PFO. A 35 mm Amplatzer septal occluder was deployed to reduce the right-to-left shunt as an urgent procedure. Tricuspid and pulmonary valve replacements were electively performed using ON-X mechanical prostheses (31/33 mm and 19 mm, respectively) 70 days after the percutaneous procedure. Transcatheter closure of a PFO prior to definitive right-sided valve surgery can be a useful treatment for CHD patients with acute haemodynamic derangement.

Profound hypoxaemia corrected by PFO closure device in carcinoid heart disease.

A 66-year-old man with known metastatic carcinoid tumor presented with increasing dyspnoea, right heart failure and marked hypoxaemia which did not correct with oxygen. Echocardiography demonstrated severe tricuspid regurgitation, moderate pulmonary regurgitation and marked right heart dilatation. The inter-atrial septum was aneurysmal, with a large patent foramen ovale (PFO) with continuous right to left shunting. Cardiac catheterization demonstrated oxygen saturations of 96% in the pulmonary veins and 74% in the left atrium with a significant right to left shunt. During percutaneous closure of the PFO, anaesthetic induction resulted in marked systemic hypotension and worsening hypoxia related to systemic vasodilatation and increased shunting. PFO flow was temporarily obstructed with a sizing balloon resulting in a rapid increase in arterial oxygen saturation from 60% to >90%, but marked systemic hypotension due to acute left ventricular preload reduction, requiring volume replacement and adrenaline. Following deployment of a PFO occluder device, prominent pulsatile splaying of the right and left discs was noted due to the severe tricuspid regurgitation, resulting in some residual inter-atrial shunting. Arterial oxygen saturation was 83%, increasing to 92% at day 4 post-procedure as tissue organization occurred within the device, and the patient reported improvement in dyspnoea.

Closure of secundum atrial septal defects with the Amplatzer septal occluder device: techniques and problems.

Percutaneous transvenous closure of atrial septal defects (ASDs) has become feasible in recent years, as later-generation devices have largely overcome initial difficulties in device deployment and complication rates. The Amplatzer septal occluder (ASO) is one such device that we have used extensively and is, in our opinion, the most versatile and practical to use. It is capable of closing defects up to 40 mm in diameter via a relatively low-profile delivery sheath. More importantly, the ASO may be easily withdrawn into the sheath after deployment but prior to release, which is essential in safely closing difficult defects where successful positioning on the initial deployment is not guaranteed. In this article based on our experience, review of the literature, and communications with other operators, we describe the various problems encountered in closing atrial septal defects and make suggestions as to the best way of overcoming these difficulties.