Innovations: Technology and Techniques in Cardiothoracic and Vascular Surgery

To define the benefit of sutureless and rapid deployment valves in current minimally invasive approaches in isolated aortic valve replacement.

A panel of 28 international experts with expertise in both minimally invasive aortic valve replacement and rapid deployment valves was constituted. After thorough literature review, the experts rated evidence-based recommendations in a modified Delphi approach.

No guideline could be retrieved. Thirty-three clinical trials and 9 systematic reviews could be identified for detailed text analysis to obtain a total of 24 recommendations. After rating by the experts 12, final recommendations were identified: preoperative computed to-mographic scan as well as intraoperative transesophageal echocardiography are highly recommended. Suitable annular sizes are 19 to 27 mm. There is a contraindication for bicuspid valves only for type 0 and for annular abscess or destruction due to infective endocarditis. The use of sutureless and rapid deployment valves reduces extracorporeal circulation and aortic cross-clamp time and leads to less early complications as prolonged ventilation, blood transfusion, atrial fibrillation, pleural effusions, paravalvular leakages and aortic regurgitation, and renal replacement therapy, respectively. These clinical outcomes result in reduced intensive care unit and hospital stay and reduced costs. The use of sutureless and rapid deployment valves will lead to a higher adoption rate of minimally invasive approaches in aortic valve replacement. Respect should be taken to a necessary short learning curve for both sutureless and minimally invasive programs.

Sutureless and rapid deployment aortic valve replacement together with minimally invasive approaches offers an attractive option in aortic valve placement for patients requiring biological valve replacement.

To define the benefit of sutureless and rapid deployment valves in current minimally invasive approaches in isolated aortic valve replacement.

A panel of 28 international experts with expertise in both minimally invasive aortic valve replacement and rapid deployment valves was constituted. After thorough literature review, the experts rated evidence-based recommendations in a modified Delphi approach.

No guideline could be retrieved. Thirty-three clinical trials and 9 systematic reviews could be identified for detailed text analysis to obtain a total of 24 recommendations. After rating by the experts 12, final recommendations were identified: preoperative computed to-mographic scan as well as intraoperative transesophageal echocardiography are highly recommended. Suitable annular sizes are 19 to 27 mm. There is a contraindication for bicuspid valves only for type 0 and for annular abscess or destruction due to infective endocarditis. The use of sutureless and rapid deployment valves reduces extracorporeal circulation and aortic cross-clamp time and leads to less early complications as prolonged ventilation, blood transfusion, atrial fibrillation, pleural effusions, paravalvular leakages and aortic regurgitation, and renal replacement therapy, respectively. These clinical outcomes result in reduced intensive care unit and hospital stay and reduced costs. The use of sutureless and rapid deployment valves will lead to a higher adoption rate of minimally invasive approaches in aortic valve replacement. Respect should be taken to a necessary short learning curve for both sutureless and minimally invasive programs.

Sutureless and rapid deployment aortic valve replacement together with minimally invasive approaches offers an attractive option in aortic valve placement for patients requiring biological valve replacement.

A small number of transcatheter mitral valve implants (TMVIs) have been reported using devices designed to treat secondary mitral regurgitation (MR). However, MR has many etiologies, and patients have a broad spectrum of annular size, geometry, and lesions. There are a number of technical challenges for TMVI including left ventricular outflow tract obstruction and paravalvular MR. Thirty days’ outcome of first-in-man implants with a novel TMVI device is reported.

The Tendyne TMVI system consists of a porcine pericardial valve in a tethered nitinol frame. An apical tether fixed to an epicardial pad stabilizes the device. The device is fully repositionable and retrievable even after complete deployment. Preoperative assessment was performed with 3-dimensional (3D) transesophageal echocardiogram and multislice computed tomography to define annular dimensions, geometry, and guide surgical access. Three patients were deemed not to be candidates for conventional surgery or for treatment with any Conformitè Européenne-marked device by Heart Team Evaluation. They were a 68-year-old woman with prior coronary artery bypass grafts and severe functional MR; a 75-year-old man with prior coronary bypass grafts, significant renal dysfunction, and severe degenerative MR; and a frail 86-year-old man with severe degenerative MR. Each had a TMVI via a transapical approach through a left minithoracotomy. Apical tether tension was adjusted to optimize device position.

Implantation was guided by 2D and 3D transesophageal echocardiogram. The apical pad facilitated LV apical closure. There were no procedural complications. No patient had hemodynamically significant residual MR or left ventricular outflow tract obstruction, and there was no significant mitral gradient. All patients were discharged to their own home (the third on the fifth postoperative day), all with significant improvement in their symptoms. All were alive and well 30 days after implant. Two patients with existing conduction abnormalities had cardiac resynchronisation therapy after the procedure, and one patient had para valvular leak (PVL) with evidence of hemolysis at 30 days, which reduced in severity with conservative treatment.

The first-in-man experience with the Tendyne TMVI system is promising. Valve stabilization by an apical tether is a novel way to address some of the challenges of TMVI. The unique Tendyne design features may offer potential for its use across a wide range of mitral valve pathologies.

A small number of transcatheter mitral valve implants (TMVIs) have been reported using devices designed to treat secondary mitral regurgitation (MR). However, MR has many etiologies, and patients have a broad spectrum of annular size, geometry, and lesions. There are a number of technical challenges for TMVI including left ventricular outflow tract obstruction and paravalvular MR. Thirty days’ outcome of first-in-man implants with a novel TMVI device is reported.

The Tendyne TMVI system consists of a porcine pericardial valve in a tethered nitinol frame. An apical tether fixed to an epicardial pad stabilizes the device. The device is fully repositionable and retrievable even after complete deployment. Preoperative assessment was performed with 3-dimensional (3D) transesophageal echocardiogram and multislice computed tomography to define annular dimensions, geometry, and guide surgical access. Three patients were deemed not to be candidates for conventional surgery or for treatment with any Conformitè Européenne-marked device by Heart Team Evaluation. They were a 68-year-old woman with prior coronary artery bypass grafts and severe functional MR; a 75-year-old man with prior coronary bypass grafts, significant renal dysfunction, and severe degenerative MR; and a frail 86-year-old man with severe degenerative MR. Each had a TMVI via a transapical approach through a left minithoracotomy. Apical tether tension was adjusted to optimize device position.

Implantation was guided by 2D and 3D transesophageal echocardiogram. The apical pad facilitated LV apical closure. There were no procedural complications. No patient had hemodynamically significant residual MR or left ventricular outflow tract obstruction, and there was no significant mitral gradient. All patients were discharged to their own home (the third on the fifth postoperative day), all with significant improvement in their symptoms. All were alive and well 30 days after implant. Two patients with existing conduction abnormalities had cardiac resynchronisation therapy after the procedure, and one patient had para valvular leak (PVL) with evidence of hemolysis at 30 days, which reduced in severity with conservative treatment.

The first-in-man experience with the Tendyne TMVI system is promising. Valve stabilization by an apical tether is a novel way to address some of the challenges of TMVI. The unique Tendyne design features may offer potential for its use across a wide range of mitral valve pathologies.

A bespoke clinical pathway is increasingly often used to expedite patient's recovery after video-assisted thoracoscopic surgery (VATS). The importance and predictors of adherence to a clinical pathway have not been previously investigated.

A defined clinical pathway was used for the perioperative management of 136 consecutive patients receiving major pulmonary resection surgery. The clinical pathway encompassed multiple aspects of clinical care, including chest drainage, analgesia, mobilization, physiotherapy, investigations, etc.

The cohort consisted of 76 males (56%), and had a median age of 61 years (range, 14–84). A single lobectomy was performed in 66 patients (49%), with sublobar or more complex resections performed in the remainder. Although all patients were intended for a VATS approach, VATS was ultimately used to complete the procedure in 113 patients (83%). It was impossible to adhere strictly to the clinical pathway throughout the hospital stay of most patients, with 83 patients (61%) found to have adhered to the clinical pathway for 50% or more or the duration of their in-hospital stay. The rate of adherence to the clinical pathway for 50% or more of the time was lower in patients who were male (31.6% vs 48.3%, P = 0.047); had a smoking history (25.9% vs 47.6%, P = 0.011); and did not have absence of pain immediately after surgery (33.9% vs 59.3%, P = 0.016). There were trends for poorer adherence among patients who had: age older than 65 years; previous tuberculosis; body mass index greater than 25 kg/m²; and longer operation times—but these failed to reach statistical significance. The approach and extent of surgery did not influence clinical pathway adherence. Adherence for 50% or more of the hospital stay was associated with reduced mean chest drain duration (3.2 ± 1.7 vs 5.1 ±5.0 days, P = 0.002) and mean length of stay (4.6 ± 1.9 vs 7.9 ± 6.6 days, P < 0.001). Among smokers, adherence for 75% or more of the hospital stay was particularly well predicted by better pain control on the day of surgery, and was in turn associated with a significant reduction in morbidity rate (7.7% vs 39.0%, P = 0.043).

Good adherence to a detailed clinical pathway may ensure faster recovery after VATS but is often difficult to maintain postoperatively. Predictors of poor adherence include male sex, smoking history, and immediate postoperative pain. Smokers are at particular risk for failure to adhere but paradoxically have the most to gain from adhering to the clinical pathway.

A bespoke clinical pathway is increasingly often used to expedite patient's recovery after video-assisted thoracoscopic surgery (VATS). The importance and predictors of adherence to a clinical pathway have not been previously investigated.

A defined clinical pathway was used for the perioperative management of 136 consecutive patients receiving major pulmonary resection surgery. The clinical pathway encompassed multiple aspects of clinical care, including chest drainage, analgesia, mobilization, physiotherapy, investigations, etc.

The cohort consisted of 76 males (56%), and had a median age of 61 years (range, 14–84). A single lobectomy was performed in 66 patients (49%), with sublobar or more complex resections performed in the remainder. Although all patients were intended for a VATS approach, VATS was ultimately used to complete the procedure in 113 patients (83%). It was impossible to adhere strictly to the clinical pathway throughout the hospital stay of most patients, with 83 patients (61%) found to have adhered to the clinical pathway for 50% or more or the duration of their in-hospital stay. The rate of adherence to the clinical pathway for 50% or more of the time was lower in patients who were male (31.6% vs 48.3%, P = 0.047); had a smoking history (25.9% vs 47.6%, P = 0.011); and did not have absence of pain immediately after surgery (33.9% vs 59.3%, P = 0.016). There were trends for poorer adherence among patients who had: age older than 65 years; previous tuberculosis; body mass index greater than 25 kg/m²; and longer operation times—but these failed to reach statistical significance. The approach and extent of surgery did not influence clinical pathway adherence. Adherence for 50% or more of the hospital stay was associated with reduced mean chest drain duration (3.2 ± 1.7 vs 5.1 ±5.0 days, P = 0.002) and mean length of stay (4.6 ± 1.9 vs 7.9 ± 6.6 days, P < 0.001). Among smokers, adherence for 75% or more of the hospital stay was particularly well predicted by better pain control on the day of surgery, and was in turn associated with a significant reduction in morbidity rate (7.7% vs 39.0%, P = 0.043).

Good adherence to a detailed clinical pathway may ensure faster recovery after VATS but is often difficult to maintain postoperatively. Predictors of poor adherence include male sex, smoking history, and immediate postoperative pain. Smokers are at particular risk for failure to adhere but paradoxically have the most to gain from adhering to the clinical pathway.

An embolic ischemic stroke occurs in 10% to 40% of patients with valvular infective endocarditis (IE) and confers significant morbidity. The optimal timing of valve surgery in this population is not well defined.

With the use of PubMed, EMBASE, Ovid, and Cochrane databases, a systematic review identified 14 studies through October 2015 that compared early versus delayed surgery for valvular IE complicated by an ischemic stroke. Early surgery was defined as 3 days or less in one, 7 days or less in eight, and 14 days or less in five studies. Risk ratios (RRs) were calculated by the Mantel-Haenszel method under a fixed- or random-effects model, for the outcomes of perioperative stroke, operative mortality, and 1-year survival.

A total of 833 patients (early surgery, 330; delayed surgery, 503) were included. The majority of operations were for aortic and/or mitral valve IE, with prosthetic valve IE present in 0% to 60%. Infection with Staphylococcus aureus ranged from 19% to 66%, and heart failure prevalence at the time of operation was 24% to 66%. Early surgery was associated with an increased risk of operative mortality (RR, 1.72; 95% confidence interval [CI], 1.27–2.34; P = 0.0005), which was significant regardless of surgery within the first 7 days (RR, 2.19; 95% CI, 1.45–3.31; P = 0.0002) or 14 days (RR, 1.72; 95% CI, 1.12–2.64; P = 0.01) after stroke. Surgical timing did not affect the risk of perioperative ischemic or hemorrhagic stroke or 1-year survival.

In patients with valvular IE complicated by ischemic stroke, early surgery is associated with an increased risk of operative mortality, with no observed benefit in 1-year survival.

An embolic ischemic stroke occurs in 10% to 40% of patients with valvular infective endocarditis (IE) and confers significant morbidity. The optimal timing of valve surgery in this population is not well defined.

With the use of PubMed, EMBASE, Ovid, and Cochrane databases, a systematic review identified 14 studies through October 2015 that compared early versus delayed surgery for valvular IE complicated by an ischemic stroke. Early surgery was defined as 3 days or less in one, 7 days or less in eight, and 14 days or less in five studies. Risk ratios (RRs) were calculated by the Mantel-Haenszel method under a fixed- or random-effects model, for the outcomes of perioperative stroke, operative mortality, and 1-year survival.

A total of 833 patients (early surgery, 330; delayed surgery, 503) were included. The majority of operations were for aortic and/or mitral valve IE, with prosthetic valve IE present in 0% to 60%. Infection with Staphylococcus aureus ranged from 19% to 66%, and heart failure prevalence at the time of operation was 24% to 66%. Early surgery was associated with an increased risk of operative mortality (RR, 1.72; 95% confidence interval [CI], 1.27–2.34; P = 0.0005), which was significant regardless of surgery within the first 7 days (RR, 2.19; 95% CI, 1.45–3.31; P = 0.0002) or 14 days (RR, 1.72; 95% CI, 1.12–2.64; P = 0.01) after stroke. Surgical timing did not affect the risk of perioperative ischemic or hemorrhagic stroke or 1-year survival.

In patients with valvular IE complicated by ischemic stroke, early surgery is associated with an increased risk of operative mortality, with no observed benefit in 1-year survival.

Valve-in-valve (ViV) procedures are increasingly being considered as an alternative to redo surgery for the treatment of degenerated bioprosthetic heart valves in patients with excessive reoperative risk. The objective of our study was to evaluate the feasibility of computer guidance in transcatheter heart valve (THV) implantation during ViV procedures.

Preprocedural electrocardiogram-gated computed tomography–scan images were processed using semiautomatic segmentation of the degenerated bioprosthesis’ radiopaque landmarks and of the ascending aorta. Virtual three-dimensional (3D) reconstructions were created. A virtual plane was subsequently added to the 3D reconstructions, indicating the optimal landing plane of the THV inside the tissue valve. Within a hybrid operating theater, a 3D/2D registration was used to superimpose the 3D reconstructions, while dynamic tracking was allowed to maintain the superimposition onto the fluoroscopic images. The THV was afterward implanted according to the optimal landing plane. Projection of the ascending aorta and the coronary arteries was used to assess the risk of coronary ostia obstruction.

Between January 2014 and October 2014, nine patients underwent aortic ViV procedures in our institution. Among those nine patients, five procedures were retrospectively evaluated as a validation step using the proposed method. The mean (SD) superimposition error was 1.1 (0.75) mm. Subsequently, two live cases were prospectively carried out using our approach, successfully implanting the THV inside the degenerated tissue valve.

Our study demonstrates the feasibility of a computer-guided implantation of THV in ViV procedures. Moreover, it suggests that augmented reality may increase the reliability of THV implantation inside degenerated bioprostheses through better reproducibility.

Valve-in-valve (ViV) procedures are increasingly being considered as an alternative to redo surgery for the treatment of degenerated bioprosthetic heart valves in patients with excessive reoperative risk. The objective of our study was to evaluate the feasibility of computer guidance in transcatheter heart valve (THV) implantation during ViV procedures.

Preprocedural electrocardiogram-gated computed tomography–scan images were processed using semiautomatic segmentation of the degenerated bioprosthesis’ radiopaque landmarks and of the ascending aorta. Virtual three-dimensional (3D) reconstructions were created. A virtual plane was subsequently added to the 3D reconstructions, indicating the optimal landing plane of the THV inside the tissue valve. Within a hybrid operating theater, a 3D/2D registration was used to superimpose the 3D reconstructions, while dynamic tracking was allowed to maintain the superimposition onto the fluoroscopic images. The THV was afterward implanted according to the optimal landing plane. Projection of the ascending aorta and the coronary arteries was used to assess the risk of coronary ostia obstruction.

Between January 2014 and October 2014, nine patients underwent aortic ViV procedures in our institution. Among those nine patients, five procedures were retrospectively evaluated as a validation step using the proposed method. The mean (SD) superimposition error was 1.1 (0.75) mm. Subsequently, two live cases were prospectively carried out using our approach, successfully implanting the THV inside the degenerated tissue valve.

Our study demonstrates the feasibility of a computer-guided implantation of THV in ViV procedures. Moreover, it suggests that augmented reality may increase the reliability of THV implantation inside degenerated bioprostheses through better reproducibility.

We present the first testing study on the ABLA-BOX, a new in vitro module of hybrid atrial fibrillation ablation.

ABLA-BOX consists of two chambers that mimic the epicardial and endocardial sides of the heart. The septum between chambers provides catheter access on both sites of the cardiac tissue. A circuit, filled with freshly obtained porcine blood, including a pump, an oxygenator, and a heating device, circulate the blood inside the system. Left atrial fresh tissue is mounted on a tissue holder and magnetically fixed. Epicardial and endocardial catheters are fixed on the catheter holders and blocked with the locker knob. The system allows control of ablation force, flow rate, temperature, and flow pattern.

Epicardial contact force of 100 g and endocardial force of 30 g resulted in larger lesion volumes (P < 0.001), areas (P < 0.001), and lesion diameters (P = 0.03 and P = 0.008), than the combination of 100/20 g. In addition, with a flow rate of 5 L/min, lesion volumes (P = 0.02), areas (P < 0.001), and diameters (both, P < 0.001) were significantly larger in comparison with those of 3 L/min. Furthermore, dimensions (both, P < 0.001), volume (P < 0.001), and area (P < 0.001) of the lesions at a circulating blood temperature of 38.0°C were larger than with a lower blood temperature (36.0°C). Finally, ablations made under stable flow pattern resulted in greater lesion diameters P = 0.04 and P = 0.03) as well as larger volumes (P = 0.02) and areas (P = 0.03) than under turbulent-like flow reproduced with the system rotor set to 400 rpm.

The ABLA-BOX allowed easy hybrid ablation with different setups, which can provide cardiologists and cardiac surgeons with reliable and more valuable insights.

We present the first testing study on the ABLA-BOX, a new in vitro module of hybrid atrial fibrillation ablation.

ABLA-BOX consists of two chambers that mimic the epicardial and endocardial sides of the heart. The septum between chambers provides catheter access on both sites of the cardiac tissue. A circuit, filled with freshly obtained porcine blood, including a pump, an oxygenator, and a heating device, circulate the blood inside the system. Left atrial fresh tissue is mounted on a tissue holder and magnetically fixed. Epicardial and endocardial catheters are fixed on the catheter holders and blocked with the locker knob. The system allows control of ablation force, flow rate, temperature, and flow pattern.

Epicardial contact force of 100 g and endocardial force of 30 g resulted in larger lesion volumes (P < 0.001), areas (P < 0.001), and lesion diameters (P = 0.03 and P = 0.008), than the combination of 100/20 g. In addition, with a flow rate of 5 L/min, lesion volumes (P = 0.02), areas (P < 0.001), and diameters (both, P < 0.001) were significantly larger in comparison with those of 3 L/min. Furthermore, dimensions (both, P < 0.001), volume (P < 0.001), and area (P < 0.001) of the lesions at a circulating blood temperature of 38.0°C were larger than with a lower blood temperature (36.0°C). Finally, ablations made under stable flow pattern resulted in greater lesion diameters P = 0.04 and P = 0.03) as well as larger volumes (P = 0.02) and areas (P = 0.03) than under turbulent-like flow reproduced with the system rotor set to 400 rpm.

The ABLA-BOX allowed easy hybrid ablation with different setups, which can provide cardiologists and cardiac surgeons with reliable and more valuable insights.

Even though roughly 90% of all implanted cardiac implantable electronic devices leads can be removed through conventional techniques, presence of large vegetations or thrombi, fractured leads, previous failed extraction, or long duration from implantation often impede classical transvenous extraction. In these cases, laser-assisted procedures represent a highly successful alternative and have a low procedural complication rate with major adverse events in less than 2% of cases. Unfortunately, most encountered complications are potentially fatal, which prompted us to develop a novel approach that adds additional safety measures by allowing for real-time intrathoracic visualization and intervention.

Five consecutive patients classified as high-risk patients received concomitant laser sheet extraction and right-sided uniportal video-assisted thoracic surgery for real-time intrathoracic visualization.

Complete extraction was achieved in all cases without observing major intraoperative events, and on-table extubation was feasible in all cases. No chest tube-associated or incision-related complications were encountered.

Concomitant laser sheet extraction and video-assisted thoracoscopy are feasible and may offer benefits in high-risk patients. Further studies to document the actual safety and clinical value of our procedure are warranted.

Even though roughly 90% of all implanted cardiac implantable electronic devices leads can be removed through conventional techniques, presence of large vegetations or thrombi, fractured leads, previous failed extraction, or long duration from implantation often impede classical transvenous extraction. In these cases, laser-assisted procedures represent a highly successful alternative and have a low procedural complication rate with major adverse events in less than 2% of cases. Unfortunately, most encountered complications are potentially fatal, which prompted us to develop a novel approach that adds additional safety measures by allowing for real-time intrathoracic visualization and intervention.

Five consecutive patients classified as high-risk patients received concomitant laser sheet extraction and right-sided uniportal video-assisted thoracic surgery for real-time intrathoracic visualization.

Complete extraction was achieved in all cases without observing major intraoperative events, and on-table extubation was feasible in all cases. No chest tube-associated or incision-related complications were encountered.

Concomitant laser sheet extraction and video-assisted thoracoscopy are feasible and may offer benefits in high-risk patients. Further studies to document the actual safety and clinical value of our procedure are warranted.