Background and Aims: Outcomes after surgical myectomy in hypertrophic obstructive cardiomyopathy (HOCM) patients have not been investigated in a multicentre registry with detailed clinical data. Hence, the objectives of this multicentre Dutch study are to describe the 30-day clinical outcomes after surgical myectomy, and to assess factors associated with increased 30-day complication rates. Methods: All HOCM patients (n = 335) who underwent surgery between 2012 and 2020 across 12 Dutch hospitals were analysed using data from the Netherlands Heart Registration. Multiple logistic regression analyses assessed factors associated with a higher 30-day complication rate. Results: Isolated surgical myectomy was performed in 22%, surgical myectomy with one concomitant procedure in 54%, and surgical myectomy with two or more concomitant procedures in 24%. Thirty-day complication rates concerned mortality (5%), ventricular septal defect (2%), stroke (3%), and surgical reoperation (2%). Mean resting left ventricular outflow tract (LVOT) gradient improved from 61 ± 30 mmHg to 13 ± 12 mmHg postoperatively, systolic anterior motion from 80% to 8%, and mitral regurgitation grade 3 or 4 from 31% to 6%. Low-volume hospital (<10 surgical myectomy procedures/year), female sex, and ≥2 concomitant procedures were significantly associated with increased 30-day complication rates. The adjusted 30-day complication rate was increased in low-volume hospitals (odds ratio 3.23 (95% confidence interval: 1.43–8.09); P = .007). Conclusions: Surgical myectomy with or without concomitant procedures effectively relieved LVOT obstruction in 93% of patients in this multicentre cohort. Female sex, ≥ 2 concomitant procedures, and low-volume hospitals were associated with higher 30-day complication rates. Although an inverse volume–complication relation was observed, this finding should be interpreted cautiously, and further investigation in larger sample size studies is warranted.
7 March 2021 in Innovations: Technology and Techniques in Cardiothoracic and Vascular Surgery
This preclinical study determines the feasibility and 6-month patency rates of a new distal coronary connector, the Excimer Laser Assisted Nonocclusive Anastomosis (ELANA) Heart Bypass. Twenty Dutch Landrace pigs received either a hand-sewn (n = 8) or an ELANA (n = 12) left internal thoracic artery to left anterior descending artery anastomosis, using off-pump coronary artery bypass grafting. Six-month patency rates were demonstrated by coronary angiography and histological evaluation. Throughout, procedural details and complication rates were collected. The ELANA Heart Bypass demonstrated 0% mortality and complication rates during follow-up. It was demonstrated feasible, with comparable perioperative flow measurements (ELANA vs hand-sewn, median [min to max], 24 [14 to 28] vs 17 [12 to 31] mL/min; P = 0.601) and fast construction times (3 [3 to 7] vs 31 [26 to 37] min; P < 0.001). Yet, an extra hemostatic stitch was needed in 25% of the ELANA versus 12.5% of the hand-sewn anastomoses. The 6-month patency rate of the ELANA Heart Bypass was 83.3% versus 100% in hand-sewn anastomoses. The 2 occluded ELANA-anastomoses were defined model-based errors. The ELANA Heart Bypass facilitates a sutureless distal coronary anastomosis. A design change is suggested to improve hemostasis and will be evaluated in future translational studies. This new technique is a potential alternative to hand-sewn anastomoses in (minimally invasive) coronary surgery.
Background: Sutureless coronary anastomotic devices are intended to facilitate minimally invasive coronary artery bypass grafting (MICS-CABG) by easing and eventually standardizing the anastomotic technique. Within this systematic review and meta-analysis, we aim to determine patency and to evaluate safety outcomes for the sutureless anastomoses. Methods: CENTRAL, MEDLINE, and EMBASE were searched from database start till August 2021 in a predefined search strategy combining the key concepts: ‘coronary artery bypass grafting’, ‘sutureless coronary anastomoses’, and ‘hand-sewn coronary anastomoses’ by the Boolean operation ‘AND’. Study characteristics, patient demographics, interventional details, and all available outcome data were extracted. A meta-analysis was performed on patency at longest follow-up. Safety outcomes were presented. Results: A total of eleven trials towards six sutureless anastomotic devices were included, comprising 3724 patients (490 sutureless and 3234 hand-sewn). There was no significant difference in patency at a mean follow-up duration of 546.3 (range 1.5–2691) days, with a risk ratio of 0.77 (95% CI 0.55–1.06). MACE was reported in 4.5% sutureless and 3.9% hand-sewn patients, including all-cause mortality (resp. 1.3 vs. 1.9%), myocardial infarction (resp. 1.6 vs. 1.7%), and coronary revascularization (resp. 1.8 vs. 0.5%). Incomplete hemostasis occurred in 24.8% of the sutureless anastomoses. Intra-operative device failure forced conversion to hand-sewn or redo-anastomosis in 5.8% of the sutureless cases. Conclusion: Based on the systematic review and meta-analysis including six devices, we conclude that sutureless coronary anastomotic devices appear safe and effective when used by well-trained and dedicated surgical teams.
21 March 2023 in Journal of Cardiovascular Translational Research
: Objectives: The ELANA® Heart Bypass creates a standardized sutureless anastomosis. Hereby, we investigate the influence of arteriotomy and graft size on coronary hemodynamics. Methods: A computational fluid dynamics (CFD) model was developed. Arteriotomy size (standard 1.43 mm2; varied 0.94 – 3.6 mm2) and graft diameter (standard 2.5 mm; varied 1.5 – 5.0 mm) were independent parameters. Outcome parameters were coronary pressure and flow, and fractional flow reserve (FFR). Results: The current size ELANA (arteriotomy 1.43 mm2) presented an estimated FFR 0.65 (39 mL/min). Enlarging arteriotomy increased FFR, coronary pressure, and flow. All reached a maximum once the arteriotomy (2.80 mm2) surpassed the coronary cross-sectional area (2.69 mm2, i.e. 1.85 mm diameter), presenting an estimated FFR 0.75 (46 mL/min). Increasing graft diameter was positively related to FFR, coronary pressure, and flow. Conclusion: The ratio between the required minimal coronary diameter for application and the ELANA arteriotomy size effectuates a pressure drop that could be clinically relevant. Additional research and eventual lengthening of the anastomosis is advised. Graphical
17 March 2022 in Innovations: Technology and Techniques in Cardiothoracic and Vascular Surgery
Objective: The ELANA Heart Bypass System is a new sutureless technique for coronary anastomoses. A titanium clip connects the graft with the coronary artery, whereafter the arteriotomy is performed by excimer laser. Since this anastomotic construction evidently differs from the standard hand-sewn anastomosis, we aim to evaluate the process of anastomotic healing and remodeling. Methods: Preclinical evaluation of anastomotic remodeling in 42 pigs who underwent off-pump left internal mammary artery to left anterior descending artery anastomosis by either the ELANA Heart Bypass ( n = 24) or the hand-sewn ( n = 18) technique. Anastomotic remodeling was evaluated by scanning electron microscopy and histology in short-term follow-up intervals up to 3 months. Anastomotic patency is determined by coronary angiography at latest follow-up before termination. Results: The nonendothelial surface of both the ELANA and the hand-sewn anastomoses were covered with neointima from 14 days onwards. Only half the amount of intima hyperplasia was present in the anastomotic surface of the patent ELANA anastomosis, compared with the hand-sewn anastomosis (98 [48–1358] vs 218 [108–296] µm, P = 0.001). Yet patency of the ELANA was inferior to the hand-sewn anastomoses (79% vs 100%, P = 0.06). Conclusions: This study shows the technical perioperative feasibility of the ELANA Heart Bypass System. Although limited intima hyperplasia was observed, hand-sewn anastomoses had superior patency during follow-up. The results of this trial suggest that an additional study with a new prototype is required before clinical implementation.
31 July 2022 in Journal of Vascular Surgery Cases, Innovations and Techniques
We have presented a case of a ruptured descending aortic aneurysm that was accompanied by extreme tortuosity and a pseudocoarctation at the level of the ligamentum arteriosum. We performed successful endovascular repair, covering the left subclavian artery, using a transapical-to-femoral artery (through-and-through) guidewire technique to overcome the tortuosity, with the option to perform balloon angioplasty in the case of an increased gradient over the coarctation. In the present case report, we have underlined the role of close collaborations with aortic expertise centers.