Annals of cardiothoracic surgery最新文献

Robotic coronary and intra-cardiac surgery has been available for more than 25 years. In this period, multiple studies have demonstrated the beneficial effects of robotic surgery over conventional open surgery. Throughout the years, technical developments have enabled us to perform totally endoscopic coronary artery bypass (TECAB) grafting. But these techniques remained in the hands of a small group of pioneers because of a lack of structured training programs and the absence of long-term results at that time. Currently, a renewed interest and a wide dispersion of robotic platforms, thanks to use of robotics in other disciplines, has led to an exponential increase in robotic cardiac centers both in Europe and USA. Nonetheless, this increase was slowed down in Europe as a result of the uncertainty introduced by the implementation of a revised regulatory framework for medical devices [Regulation 2017/745, 'Medical Device Regulation' ('MDR')]. The MDR was introduced with the goal of increasing patient safety and supporting innovation. Implementing the MDR has proven to be exceptionally challenging and risks to the supply of essential devices have been identified. Changes to both regulatory and market dynamics led to a circumstance where the only available robotic platform for cardiac surgery decided to cease marketing of essential accessories for conducting surgery. This resulted in the disappearance of dedicated tools such as the Endowrist stabilizer, essential for TECAB, and the atrial retractor which is essential for intra-cardiac surgery. In the mean-time, further clinical evidence was published demonstrating the superiority of robotic cardiac surgery over other minimally invasive approaches. This has demonstrated the need to better define the clinical evidence requirements for regulatory purposes to ensure that dedicated tools for evidence-based interventions in robotic coronary surgery remain available such that TECAB can continue in Europe.

Minimally invasive approaches to address coronary artery disease, such as robotic coronary bypass grafting, are emerging in surgery and have been shown to be beneficial with a reduction in morbidity. The perioperative management of this subset of patients is crucial to the success of the operation as there are several preoperative and postoperative issues and considerations that need to be addressed. A meticulous preoperative workup with an extensive history, physical exam, and appropriate imaging are instrumental to ensure a successful operation. Protocolized postoperative care is also essential to garnish the most benefit from this minimally invasive approach. All of these factors, in conjunction with a heart team approach and surgeon experience, are imperative for the successful outcome of robotic coronary artery revascularization.

Robotic-assisted coronary bypass is an attractive option in the management of patients with isolated left anterior descending artery (LAD) disease or multi-vessel coronary disease providing the benefits of the left internal mammary artery (LIMA) to the LAD graft while avoiding the morbidity of a sternotomy. Although the learning curve is significant, both cardiothoracic surgery trainees as well as experienced coronary surgeons can learn this technique. As the prevalence of patients requiring these procedures increases, we must be prepared to respond by increasing our training of robotic coronary surgeons.

Robotic technology was first used in history for the minimally invasive surgical treatment of coronary artery disease. In 1998, the first operations were carried out at the Hôpital Broussais in Paris. Thereafter, several European and United States (US) centers developed surgical concepts for robotically assisted internal mammary artery harvesting and the construction of the anastomoses, either through minithoracotomy or in a totally endoscopic fashion. Initial experiences were documented in a number of single and multicenter series published in the early and mid-2000s. Key steps in further procedure development included the introduction of a robotic endostabilizer for beating heart completely endoscopic operations, the combination with percutaneous coronary intervention in hybrid approaches, the introduction of second, third, and fourth generations of surgical robots with improvements in each iteration, the availability of anastomotic devices, and most recently, the emergence of new robotic technology companies producing interesting alternatives to the existing machines. The larger clinical series included 500 to over 1,000 patients, with clinical results that well justified the continued application of robotics. Development of robotic coronary bypass grafting has generally been slow, but at committed centers, the procedures are routine, reproducible, safe, and effective. Over 25 years of development, robotic surgical coronary revascularization has become an important component in the armamentarium of minimally invasive heart surgery.

Background: The difficulty of suturing perfect anastomoses in limited-access conditions prevents the transition of traditional coronary artery bypass grafting (CABG) to sternal-sparing approaches, even in the robotic era. Automated coronary anastomotic connector technologies may address these difficulties, but to date, none have achieved broad adoption. Besides versatility, ease-of-use and cost-effectiveness, the key performance parameter of such technology is anastomotic patency. In this meta-analysis, we aim to evaluate published connector devices by examining their patency outcomes in distal anastomoses.

Methods: The literature was systematically searched for studies comparing the angiographic patency of connector constructed coronary anastomoses to handsewn (HS) connections in adult patients undergoing CABG. The primary outcome was anastomosis patency across early (<30 days), mid-term (30 days to 1 year) and long-term (>1 year) follow-up. Random-effects meta-analyses were employed to analyze and compare patency using pooled risk ratios (RR) with 95% confidence intervals (CI).

Results: The search yielded 14 studies concerning eight connector devices. In 4,311 patients, a total of 4,328 anastomoses were constructed, 674 with connector devices and 3,654 with a HS technique. The pooled device patency over all timeframes was non-inferior to the HS technique (RR 0.90, 95% CI: 0.56-1.44). Technologies having a relatively large blood-exposed non-intimal surface area (BENIS, >15 mm²) performed acceptably when applied to large target vessels [>2.0-2.5 mm inner diameter (ID)]. A tiny anastomotic orifice area (AOA, < ca. 4 mm²) appeared to adversely affect results. Technologies realizing a generous AOA in combination with a limited BENIS showed superior results and applicability by performing well across the entire range of target coronary artery diameters (>1.0-1.5 mm ID).

Conclusions: The overall results suggest that connectors yield at least non-inferior anastomosis patency outcomes compared to HS techniques in all observed timeframes. Optimizing device characteristics like BENIS and AOA appear fundamental for broad applicability.