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Transcatheter valve implantation for patients with aortic stenosis: a position statement from the European Association of Cardio-Thoracic Surgery (EACTS) and the European Society of Cardiology (ESC), in collaboration with the European Association of Percutaneous Cardiovascular Interventions (EAPCI)

AIMS To critically review the available transcatheter aortic valve implantation techniques and their results, as well as propose recommendations for their use and development. METHODS AND RESULTS A committee of experts including European Association of Cardio-Thoracic Surgery and European Society of Cardiology representatives met to reach a consensus based on the analysis of the available data obtained with transcatheter aortic valve implantation and their own experience. The evidence suggests that this technique is feasible and provides haemodynamic and clinical improvement for up to 2 years in patients with severe symptomatic aortic stenosis at high risk or with contraindications for surgery. Questions remain mainly concerning safety and long-term durability, which have to be assessed. Surgeons and cardiologists working as a team should select candidates, perform the procedure, and assess the results. Today, the use of this technique should be restricted to high-risk patients or those with contraindications for surgery. However, this may be extended to lower risk patients if the initial promise holds to be true after careful evaluation. CONCLUSION Transcatheter aortic valve implantation is a promising technique, which may offer an alternative to conventional surgery for high-risk patients with aortic stenosis. Today, careful evaluation is needed to avoid the risk of uncontrolled diffusion.

Regular Physical Activity Improves Endothelial Function in Patients With Coronary Artery Disease by Increasing Phosphorylation of Endothelial Nitric Oxide Synthase

Background—In stable coronary artery disease (CAD), exercise training has well-documented positive effects on arterial endothelial function. NO derived from endothelial NO synthase (eNOS) is regarded as a protective factor against atherosclerosis. The aim of the present study was to investigate the effects of exercise training on the endothelial function in relation to the expression of eNOS and Akt-dependent eNOS phosphorylation in the left internal mammary artery (LIMA) of patients with stable CAD. Methods and Results—In 17 training patients (T) and 18 control patients (C), endothelium-dependent vasodilation and average peak flow velocity (APV) in response to acetylcholine were measured invasively at study beginning and after 4 weeks in the LIMA. In LIMA tissue sampled during bypass surgery, eNOS expression and content of pospho-eNOS-Ser1177, Akt, and phospho-Akt were determined by Western blot and quantitative reverse transcriptase–polymerase chain reaction. After exercise training, LIMA APV in response to acetylcholine was increased by 56±8% (from +48±8% at beginning to +104±11% after 4 weeks, P <0.001). Patients in T had a 2-fold higher eNOS protein expression (T 1.0±0.7 versus C 0.5±0.3 arbitrary units, P <0.05) and 4-fold higher eNOS Ser1177-phosphorylation levels in LIMA-endothelium (1.2±0.9 versus 0.3±0.2 arbitrary units, P <0.01). A linear correlation was confirmed between Akt phosphorylation and phospho-eNOS levels (R =0.80, P <0.05) and between phospho-eNOS and &Dgr; APV (R =0.59, P <0.05). Conclusions—Exercise training in stable CAD leads to an improved agonist-mediated endothelium-dependent vasodilatory capacity. The change in acetylcholine-induced vasodilatation was closely related to a shear stress–induced/Akt-dependent phosphorylation of eNOS on Ser1177.

Randomized Comparison of Percutaneous Coronary Intervention With Sirolimus-Eluting Stents Versus Coronary Artery Bypass Grafting in Unprotected Left Main Stem Stenosis

OBJECTIVES The purpose of this randomized study was to compare sirolimus-eluting stenting with coronary artery bypass grafting (CABG) for patients with unprotected left main (ULM) coronary artery disease. BACKGROUND CABG is considered the standard of care for treatment of ULM. Improvements in percutaneous coronary intervention (PCI) with use of drug-eluting stents might lead to similar results. The effectiveness of drug-eluting stenting versus surgery has not been established in a randomized trial. METHODS In this prospective, multicenter, randomized trial, 201 patients with ULM disease were randomly assigned to undergo sirolimus-eluting stenting (n = 100) or CABG using predominantly arterial grafts (n = 101). The primary clinical end point was noninferiority in freedom from major adverse cardiac events, such as cardiac death, myocardial infarction, and the need for target vessel revascularization within 12 months. RESULTS The combined primary end point was reached in 13.9% of patients after surgery, as opposed to 19.0% after PCI (p = 0.19 for noninferiority). The combined rates for death and myocardial infarction were comparable (surgery, 7.9% vs. stenting, 5.0%; noninferiority p < 0.001), but stenting was inferior to surgery for repeat revascularization (5.9% vs. 14.0%; noninferiority p = 0.35). Perioperative complications including 2 strokes were higher after surgery (4% vs. 30%; p < 0.001). Freedom from angina was similar between groups (p = 0.33). CONCLUSIONS In patients with ULM stenosis, PCI with sirolimus-eluting stents did not show noninferiority [corrected] to CABG at 12-month follow-up with respect to freedom from major adverse cardiac events, which is mainly influenced by repeated revascularization, whereas for hard endpoints, [corrected] PCI results are favorable. A longer follow-up is warranted. [corrected]

Treatment of complex coronary artery disease in patients with diabetes: 5-year results comparing outcomes of bypass surgery and percutaneous coronary intervention in the SYNTAX trial

OBJECTIVES This prespecified subgroup analysis examined the effect of diabetes on left main coronary disease (LM) and/or three-vessel disease (3VD) in patients treated with percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) in the SYNTAX trial. METHODS Patients (n = 1800) with LM and/or 3VD were randomized to receive either PCI with TAXUS Express paclitaxel-eluting stents or CABG. Five-year outcomes in subgroups with (n = 452) or without (n = 1348) diabetes were examined: major adverse cardiac or cerebrovascular events (MACCE), the composite safety end-point of all-cause death/stroke/myocardial infarction (MI) and individual MACCE components death, stroke, MI and repeat revascularization. Event rates were estimated with Kaplan-Meier analyses. RESULTS In diabetic patients, 5-year rates were significantly higher for PCI vs CABG for MACCE (PCI: 46.5% vs CABG: 29.0%; P < 0.001) and repeat revascularization (PCI: 35.3% vs CABG: 14.6%; P < 0.001). There was no difference in the composite of all-cause death/stroke/MI (PCI: 23.9% vs CABG: 19.1%; P = 0.26) or individual components all-cause death (PCI: 19.5% vs CABG: 12.9%; P = 0.065), stroke (PCI: 3.0% vs CABG: 4.7%; P = 0.34) or MI (PCI: 9.0% vs CABG: 5.4%; P = 0.20). In non-diabetic patients, rates with PCI were also higher for MACCE (PCI: 34.1% vs CABG: 26.3%; P = 0.002) and repeat revascularization (PCI: 22.8% vs CABG: 13.4%; P < 0.001), but not for the composite end-point of all-cause death/stroke/MI (PCI: 19.8% vs CABG: 15.9%; P = 0.069). There were no differences in all-cause death (PCI: 12.0% vs CABG: 10.9%; P = 0.48) or stroke (PCI: 2.2% vs CABG: 3.5%; P = 0.15), but rates of MI (PCI: 9.9% vs CABG: 3.4%; P < 0.001) were significantly increased in the PCI arm in non-diabetic patients. CONCLUSIONS In both diabetic and non-diabetic patients, PCI resulted in higher rates of MACCE and repeat revascularization at 5 years. Although PCI is a potential treatment option in patients with less-complex lesions, CABG should be the revascularization option of choice for patients with more-complex anatomic disease, especially with concurrent diabetes.

Intraoperative Radiofrequency Ablation of Chronic Atrial Fibrillation: A Left Atrial Curative Approach by Elimination of Anatomic “Anchor” Reentrant Circuits

Intraoperative Ablation of Atrial Fibrillation. Introduction: The percutaneous approach to radiofrequency (RF) catheter ablation for curative treatment of atrial fibrillation (AF) is an investigational technique, and the optimal composition of lesion lines is unknown. We tested an intraoperative RF ablation concept with elimination of left atrial anatomic “anchor” reentrant circuits.

The evolution of minimally invasive mitral valve surgery – 2 year experience

Objectives: The aim of the study was to evaluate the evolution of Port-Access minimally invasive mitral valve surgery to a robot assisted video assisted solo surgery approach. Methods: One hundred and twenty-nine patients with non-ischemic mitral valve disease underwent 3D-video assisted mitral valve surgery via a 4 cm right lateral minithoracotomy using femoro-femoral bypass and endoaortic clamping. Transcranial Doppler and continuous transesophageal echocardiography were used to monitor placement and positional stability of the endoclamp. After the initial series (group I, n = 62), a simplified solo surgical technique using voice controlled robotic assistance for videoscope guidance was used in the last 67 patients (group II). Results: After an initial learning curve and modifications of catheter design, the procedure could be steadily redefined and simplified. In the last 67 patients, the procedure was completed without the need for an additional assistant as ‘solo surgery’. The mitral valve was repaired in 72 and replaced in all other patients. Duration of bypass and clamp time steadily improved during our study and in the most recent 67 patients average 107 ∠ 34 and 48 ∠ 16 min, respectively. The voice controlled robotic arm (AESOP 3000, Automated Endoscope System for Optimal Positioning) provided a stable and precise video image with excellent exposure of all valvular and subvalvular structures. Hospital mortality was high in the early series (mean survival 88.7% at 804 ∠ 35 days; 95% CI: 735‐873) and partially procedure related (aortic dissection in two patients). In group II, hospital mortality has declined to 3.0% (mean survival 97.0% at 568 ∠ 12 days; 95% CI: 553‐600). Conclusion: Port-Access minimally invasive mitral valve surgery has evolved to be a reliable video assisted technique with reproducible results. Surgery can now be performed almost in the same time as with conventional techniques. Robotic assistance has enabled a solo surgery approach.

Randomized Comparison of Minimally Invasive Direct Coronary Artery Bypass Surgery Versus Sirolimus-Eluting Stenting in Isolated Proximal Left Anterior Descending Coronary Artery Stenosis

OBJECTIVES The purpose of this randomized study was to compare sirolimus-eluting stenting (SES) with minimally invasive direct coronary artery bypass (MIDCAB) surgery for patients with isolated proximal left anterior descending (LAD) coronary artery disease. BACKGROUND Bare-metal stenting is inferior to MIDCAB surgery in patients with isolated proximal LAD lesions due to a higher reintervention rate with similar results for mortality and reinfarction. SES are effective in restenosis reduction. METHODS A total of 130 patients with significant proximal LAD coronary artery disease were randomized to either SES (n = 65) or MIDCAB surgery (n = 65). The primary clinical end point was noninferiority in freedom from major adverse cardiac events (MACE), such as cardiac death, myocardial infarction, and the need for target vessel revascularization within 12 months. RESULTS Follow-up was completed for all patients. MACE occurred in 7.7% of patients after stenting, as compared with 7.7% after surgery (p = 0.03 for noninferiority). The individual components of the combined end point revealed mixed results. Although noninferiority was revealed for the difference in death and myocardial infarction (1.5% vs. 7.7%, noninferiority p < 0.001), noninferiority was not established for the difference in target vessel revascularization (6.2% vs. 0%, noninferiority p = 0.21). Clinical symptoms improved significantly in both treatment groups in comparison with baseline, and the percentage of patients free from angina after 12 months was 81% versus 74% (p = 0.49). CONCLUSIONS In isolated proximal LAD disease, SES is noninferior to MIDCAB surgery at 12-month follow-up with respect to MACE at a similar relief in clinical symptoms.

Surgical risk of preoperative malperfusion in acute type A aortic dissection

OBJECTIVE Patients who have type A dissection with preoperative malperfusion syndromes are believed to be at extremely high surgical risk. Our aim was to evaluate perioperative and long-term results of patients with preoperative malperfusion. METHODS A total of 276 patients (174 men; mean age 59.5 +/- 13.4 years) underwent surgery for acute type A dissection between October 1994 and January 2008. Preoperative malperfusion syndromes were diagnosed in 93 (33.7%) patients (group I) and involved coronary circulation in 41 (15%) patients, central nervous system in 39 (14%) patients, limb ischemia in 32 (11.6%) patients, and mesenteric circulation in 8 (3%) patients. Postoperative results were compared between patients with preoperative malperfusion and those without this complication (group II, n = 183). RESULTS In-hospital mortality was 29.0% in group I versus 13.6% in group II (P = .002). The postoperative intensive care unit stay was longer (11.4 +/- 9.7 vs 7.7 +/- 6.9 days; P = .04) in the malperfusion group. A total of 6 (75%) patients with mesenteric malperfusion died. Long-term follow-up (range, 1-122 months postoperatively) was available in 100% of survivors. One-year and 5-year overall survivals were 49.8% +/- 11.8% and 41.8% +/- 12.6% in group I versus 70.4% +/- 7.6% and 56% +/- 10.4% in group II (P = .005). Cox regression analysis identified preoperative malperfusion as a significant risk factor for long-term mortality after surgery for type A dissection (hazard ratio, 1.7; 95% confidence intervals, 1.2-3.1). CONCLUSIONS Preoperative malperfusion is a significant risk factor influencing perioperative and long-term survival after surgery for acute type A dissection. Percutaneous interventional procedures and delayed surgery should be considered in patients with clinically apparent mesenteric malperfusion because of the dismal prognosis of immediate surgical therapy.

Transapical transcatheter aortic valve implantation using the JenaValve™ system: acute and 30-day results of the multicentre CE-mark study†

OBJECTIVES Transcatheter aortic valve implantation (TAVI) has shown promising results in patients with severe aortic stenosis (AS) at high risk for conventional heart surgery. The safety and efficacy of transapical aortic valve implantation using the JenaValve™, a second-generation TAVI device, were evaluated. The system consists of a tested porcine root valve mounted on a nitinol stent with feeler-guided positioning and clip fixation on the diseased leaflets. METHODS This multicentre, prospective, single-arm study, conducted at seven German sites, enrolled 73 patients (mean age 83.1 ± 3.9), European System for Cardiac Operative Risk Evaluation (EuroSCORE) (28.4 ± 6.5%) of whom 67 patients underwent elective TAVI. Three sizes were used for annular diameters up to 23 mm (n = 21), 25 mm (n = 31) and 27 mm (n = 15). Clinical and echocardiographic evaluations were performed at baseline, post-procedure, discharge and 30 days, and also at 3, 6 and 12 months. The primary endpoint was all-cause mortality at 30 days. Secondary endpoints were procedural success, major adverse cardiac and cerebrovascular events and echocardiographic performance. RESULTS TAVI with the JenaValve™ device was successful in 60 patients (procedural success rate 89.6%). The overall mortality at 30 days was 7.6%. Conversion to surgery was necessary in four patients (6%), two patients underwent valve-in-valve implantations (3%), one patient was withdrawn per protocol after conversion to TAVI using a balloon-expandable valve (1.5%) since the patient did not receive the study device. Perioperative stroke occurred in two cases (3%). Pacemaker implantation for new onset conduction disorders was necessary in six patients (9.1%). No ostial coronary obstructions were seen. Post-procedure TAVI resulted in favourable reduction of mean transvalvular gradients (40.6 ± 15.9 vs. 10.0 ± 7.2 mmHg, P < 0.0001) and increase in valve opening area (0.7 ± 0.2 vs. 1.7 ± 0.6 cm², P < 0.0001). The majority of successfully treated patients revealed no or minimal paravalvular aortic regurgitation (86.4%); none of the patients had severe post-procedural regurgitation (>2+). CONCLUSIONS Transapical JenaValve™ implantation was safe and effective in the treatment of severe AS in elderly patients at high risk for surgery. Active clip fixation on the native leaflets and anatomically correct feeler-guided positioning led to good functionality and prevented ostial coronary impairment. Implantation without the need for rapid pacing prevented haemodynamic compromise during valve implantation.

Quality of computer enhanced totally endoscopic coronary bypass graft anastomosis – comparison to conventional technique

OBJECTIVE Aims of the study were to develop an endoscopic technique to perform robot assisted coronary anastomoses, using a computer enhanced telemanipulator and to compare the quality of the anastomoses with those performed using a standard open technique. METHODS A surgical telemanipulator with two instrument arms and a central videoscopic arm was used to perform remote endoscopic coronary artery bypass grafting on isolated porcine hearts. The end effectors and the videoscope were placed through three 10 mm port incisions. All anastomoses (Cx to LAD) were performed using a double armed 7-0 Prolene suture of 5 or 7 cm in length. All operations were performed remotely from the master console using ten times magnification, tremor filtering and 3:1 motion scaling. Initially 20 anastomoses were performed to develop and train the technique. Then, 20 robot-assisted anastomoses (group I) were compared with 20 anastomoses using a standard open parachute technique (group II). All anastomoses were checked for patency and leakage. Patency was confirmed by bench angiography. After fixation, all anastomoses were macroscopically evaluated for patency, intactness, alignment, intimal tears and dehiscence. Both angiographic and pathologic evaluations were performed with the examiners blinded to the technique of anastomosis. RESULTS In the initial feasibility series, time for anastomosis was 18.2 +/- 9.1 min. All anastomoses were patent although minor stenoses were found in two and minor leakage was noted in five anastomoses. In the second series all anastomoses were patent, not leaking and showed a good run-off at angiography. Mean time for anastomosis in group I was 12.8 +/- 2.4 min as compared with 6.3 +/- 0.2 min in group II (P < 0.001), respectively. Macroscopic analysis demonstrated equal quality for both groups. There were no stenoses, no intimal tears and no dehiscences. All anastomoses had a normal alignment and intact suture lines. CONCLUSION Using the Intuitive surgical telemanipulator, it is possible to remotely perform endoscopic coronary anastomoses with the same quality as with an open standard technique after a brief learning curve. This will enable true endoscopic coronary artery bypass grafting with a precision that has not been achieved with any other previously applied endoscopic technique.