Percutaneous Ventricular Restoration Prevents Left Ventricular Remodeling Post Myocardial Infarction: One-Year Evaluation of the Heartech First-in-man Study.

BACKGROUND: This is first-in-man investigation of an implantable Heartech left ventricular partitioning device (LVPD) therapy for chronic heart failure (HF) after a myocardial infarction. METHODS AND RESULTS: Initially, 16 patients were chosen from 3 cardiac centers within China. All patients were treated with percutaneous ventricular restoration involving the Heartech LVPD implantation. Major adverse cardiovascular and cerebrovascular events were documented. Functional status, echocardiograph evaluation, European five-dimensional health scale, 6-minute walk test before the procedure and at postoperative follow-ups were recorded. We demonstrated successful implantation and device function with a success rate of 93.75%. One patient suffered a fatal myocardial infarction within the 12 ± 1 month follow-up. However, other patients did not report any major adverse cardiovascular and cerebrovascular events at their 12 ± 1 month follow-ups. After the operation, the average left ventricular end-systolic volume index decreased dramatically (66.00 mL/m2, interquartile range [IQR] 63.00-89.00 mL/m2 vs 48.00 mL/m2, IQR 32.25-68.25 mL/m2, P = .001), along with the left ventricular end-diastolic volume index (105.00 mL/m2, IQR 90.00-130.00 mL/m2 vs 76.50 mL/m2, IQR 57.75-120.25 mL/m2, P = .002). The left ventricular ejection fraction (35.00%, IQR 27.00-38.00% vs 42.50%, IQR 34.75-50.25%, P = .003), 6-minute walk test (383.13 ± 108.70 m vs 491.17 ± 118.44 m, P = .01), and European five-dimensional health scale (65.93 ± 11.25 vs 82.50 ± 5.44, P < .001), in turn, improved significantly. CONCLUSIONS: In our study, the Heartech LVPD was demonstrated as both safe and effective in reducing LV volume, enhancing LV function after implantation. These results remain constant at least till the 12 month follow-up. (Trial Registration: NCT02938637.).

Transcatheter or Surgical Aortic Valve Replacement in Women With Small Annuli at Low or Intermediate Surgical Risk.

There are limited data from randomized controlled trials assessing the impact of transcatheter aortic valve replacement (TAVR) or surgery in women with aortic stenosis and small aortic annuli. We evaluated 2-year clinical and hemodynamic outcomes after aortic valve replacement to understand acute valve performance and early and midterm clinical outcomes. This post hoc analysis pooled women enrolled in the randomized, prospective, multicenter Evolut Low Risk and Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI) intermediate risk trials. Women with severe aortic stenosis at low or intermediate surgical risk who had a computed tomography-measured annular perimeter of ≤72.3 mm were included and underwent self-expanding, supra-annular TAVR or surgery. The primary end point was 2-year all-cause mortality or disabling stroke rate. The study included 620 women (323 TAVR, 297 surgery) with a mean age of 78 years. At 2 years, the all-cause mortality or disabling stroke was 6.5% for TAVR and 8.0% for surgery, p = 0.47. Pacemaker rates were 20.0% for TAVR and 8.3% for surgery, p <0.001. The mean effective orifice area at 2 years was 1.9 ± 0.5 cm2 for TAVR and 1.6 ± 0.5 cm2 for surgery and the mean gradient was 8.0 ± 4.1 versus 12.7 ± 6.0 mm Hg, respectively (both p <0.001). Moderate or severe patient-prothesis mismatch at discharge occurred in 10.9% of patients who underwent TAVR and 33.2% of patients who underwent surgery, p <0.001. In conclusion, in women with small annuli, the clinical outcomes to 2 years were similar between self-expanding, supra-annular TAVR and surgery, with better hemodynamics in the TAVR group and fewer pacemakers in the surgical group.

Transcatheter aortic valve implantation in patients with bicuspid valve morphology: a roadmap towards standardization.

Indications for transcatheter aortic valve implantation (TAVI) have expanded in many countries to include patients with aortic stenosis who are at low surgical risk, and a similar expansion to this cohort is anticipated elsewhere in the world, together with an increase in the proportion of patients with bicuspid aortic valve (BAV) morphology as the age of the patients being treated decreases. To date, patients with BAV have been excluded from major randomized trials of TAVI owing to anatomical considerations. As a consequence, BAV has been a relative contraindication to the use of TAVI in international guidelines. Although clinical experience and observational data are accumulating, BAV presents numerous anatomical challenges for successful TAVI, despite advances in device design. Furthermore, in those with BAV, substantial geographical variation exists in patient characteristics, clinical approach and procedural strategy. Therefore, in this Roadmap article, we summarize the existing evidence and provide consensus recommendations from an international group of experts on the application of TAVI in patients with BAV in advance of the anticipated growth in the use of this procedure in this challenging cohort of patients.

Transcatheter mitral valve replacement or repair for secondary mitral regurgitation: a propensity score-matched analysis.

AIMS: This study aimed to compare outcomes after transcatheter mitral valve replacement (TMVR) and mitral valve transcatheter edge-to-edge repair (M-TEER) for the treatment of secondary mitral regurgitation (SMR). METHODS AND RESULTS: The CHOICE-MI registry included 262 patients with SMR treated with TMVR between 2014 and 2022. The EuroSMR registry included 1065 patients with SMR treated with M-TEER between 2014 and 2019. Propensity score (PS) matching was performed for 12 demographic, clinical and echocardiographic parameters. Echocardiographic, functional and clinical outcomes out to 1 year were compared in the matched cohorts. After PS matching, 235 TMVR patients (75.5 years [70.0, 80.0], 60.2% male, EuroSCORE II 6.3% [interquartile range 3.8, 12.4]) were compared to 411 M-TEER patients (76.7 years [70.1, 80.5], 59.0% male, EuroSCORE II 6.7% [3.9, 12.4]). All-cause mortality was 6.8% after TMVR and 3.8% after M-TEER at 30 days (p = 0.11), and 25.8% after TMVR and 18.9% after M-TEER at 1 year (p = 0.056). No differences in mortality after 1 year were found between both groups in a 30-day landmark analysis (TMVR: 20.4%, M-TEER: 15.8%, p = 0.21). Compared to M-TEER, TMVR resulted in more effective mitral regurgitation (MR) reduction (residual MR ≤1+ at discharge for TMVR vs. M-TEER: 95.8% vs. 68.8%, p < 0.001), and superior symptomatic improvement (New York Heart Association class ≤II at 1 year: 77.8% vs. 64.3%, p = 0.015). CONCLUSION: In this PS-matched comparison between TMVR and M-TEER in patients with severe SMR, TMVR was associated with superior reduction of MR and superior symptomatic improvement. While post-procedural mortality tended to be higher after TMVR, no significant differences in mortality were found beyond 30 days.

Anatomical morphology of the aortic valve in Chinese aortic stenosis patients and clinical results after downsize strategy of transcatheter aortic valve replacement.

BACKGROUND: The study aimed to describe the aortic valve morphology in Chinese patients underwent transcatheter aortic valve replacement (TAVR) for symptomatic severe aortic stenosis (AS), and the impact of sizing strategies and related procedural outcomes. METHODS: Patients with severe AS who underwent TAVR were consecutively enrolled from 2012 to 2019. The anatomy and morphology of the aortic root were assessed. "Downsize" strategy was preformed when patients had complex morphology. The clinical outcomes of patients who performed downsize strategy were compared with those received annular sizing strategy. The primary outcome was device success rate, and secondary outcomes included Valve Academic Research Consortium-3 clinical outcomes variables based on 1-year follow-up. RESULTS: A total of 293 patients were enrolled. Among them, 95 patients (32.4%) had bicuspid aortic valve. The calcium volume (Hounsfield Unit-850) of aortic root was 449.90 (243.15-782.15) mm 3 . Calcium is distributed mostly on the leaflet level. Downsize strategy was performed in 204 patients (69.6%). Compared with the patients who performed annular sizing strategy, those received downsize strategy achieved a similar device success rate (82.0% [73] vs . 83.3% [170], P  = 0.79). Aortic valve gradients (downsize strategy group vs . annular sizing group, 11.28 mmHg vs. 11.88 mmHg, P  = 0.64) and percentages of patients with moderate or severe paravalvular regurgitation 2.0% (4/204) vs . 4.5% (4/89), P  = 0.21) were similar in the two groups at 30 days after TAVR. These echocardiographic results were sustainable for one year. CONCLUSIONS: Chinese TAVR patients have more prevalent bicuspid morphology and large calcium volume of aortic root. Calcium is distributed mostly on the leaflet level. Compare with annular sizing strategy, downsize strategy provided a non-inferior device success rate and transcatheter heart valve hemodynamic performance in self-expanding TAVR procedure.

The effect of storage solutions on endothelial function and saphenous vein graft patency.

Vein graft failure is a complex mechanism that can be triggered immediately after surgical harvesting. Storage solutions have a major role in preventing endothelial cell damage during harvesting. While normal saline is still widely used, buffered solutions seem to better preserve endothelial integrity and function. This review aims to summarize the current literature surrounding vein graft storage solutions.

Common arterial trunk repair: with conduit or without?

OBJECTIVE: To compare the mid-term results of two techniques used for the reconstruction of the pulmonary outflow tract during common arterial trunk repair in infancy, with special attention paid to re-operation rate and pulmonary arterial growth. METHODS: Between 2000 and 2006, 32 consecutive neonates or infants underwent common arterial trunk repair. In 15 patients, the pulmonary outflow tract was reconstructed using an extracardiac valved conduit (conduit group). In 17 patients, right ventricle to pulmonary artery connection was achieved without conduit, using the left atrial appendage and including a monocusp valve (non-conduit group). The decision regarding the type of ventricle to pulmonary artery connection was at the discretion of the attending surgeon. The two groups were similar in terms of age, weight, type of common arterial trunk, truncal valve dysfunction and coronary abnormalities. Follow-up was 93% complete and included echo-Doppler evaluation, catheterisation and CT scan imaging. RESULTS: Hospital mortality (five patients - 16%) was increased by coronary abnormalities and preoperative ventilation but did not differ between the two groups (13.3% in the conduit group vs 18% in the non-conduit group). The mean follow-up was 40+/-25 months. There were six late deaths (three in each group), yielding an actuarial survival of 76% at 5 years. One late death was procedure related (percutaneous dilatation for obstructive monocusp patch). Re-operation for right ventricular outflow tract obstruction was necessary in seven patients (five in the conduit group and two in the non-conduit group); the actuarial freedom from re-operation was higher in the non-conduit group (p=0.026). At last follow-up, the right ventricle-pulmonary artery gradient and the right ventricle/left ventricle pressure ratio were higher in the conduit group (p=0.006 and p=0.007, respectively). At late computed tomography (CT)-scan evaluation, the growth of the proximal pulmonary arterial tree had improved in the non-conduit group, as shown by a higher Nakata ostial index and right ventricular outflow tract growth. CONCLUSIONS: Repair of common arterial trunk without conduit for right ventricular outflow tract reconstruction (1) does not increase mortality and morbidity, (2) decreases the need for re-intervention and (3) promotes a better growth of the proximal pulmonary arteries. These preliminary results need confirmation by further experience.

Anomalous origin of the left coronary artery from the pulmonary artery: surgical treatment.

Anomalous origin of the left coronary artery from the pulmonary artery is a rare malformation in which the left coronary artery originates from the pulmonary artery. The consequences are variable although, in most cases, this anomaly leads to severe coronary hypoperfusion and left ventricular dysfunction when pulmonary vascular resistances fall in the postnatal period. Surgical correction is indicated as soon as the diagnosis is established. In nearly all cases, the anomalous artery can be excised from its pulmonary origin, mobilized and reimplanted directly into the ascending aorta. In rare circumstances, technical modifications must be used to restore a normal dual coronary perfusion. The operative risk is related mainly to the severity of preoperative left ventricular dysfunction. The current mortality rate is low, but postoperative left ventricular assist device implantation may be necessary in the most severe cases. After successful revascularization, the late results are satisfactory; left ventricular function always recovers; mitral regurgitation, if present, decreases, although reoperation may be necessary for residual ischemic mitral insufficiency.

Modified Konno operation for diffuse subaortic stenosis.

The modified Konno operation is designed to provide relief of diffuse subaortic stenosis, while preserving the native aortic valve. The aorta and the right ventricular infundibulum are opened. The upper part of the subaortic stenosis is incised through the aortic orifice. The conal septum is incised and the septotomy is extended across the stenotic area. The obstructive tissue is removed (mainly from the left-handed rim of the septotomy) and the conal septum is enlarged with a prosthetic patch. The aorta is closed and the right ventricular infundibulum is enlarged. Early and late mortality rates are low. Potential morbidity (complete heart block, residual ventricular septal defect, iatrogenic aortic insufficiency, right ventricular outflow tract obstruction) should be minimized by a careful surgical technique. The modified Konno operation is indicated in patients with diffuse subaortic stenosis and a normal aortic orifice; this includes patients with severe forms of hypertrophic obstructive cardiomyopathy and children with tunnel subaortic stenosis and a normal aortic orifice; the modified Konno procedure provides long-lasting relief of the obstruction. In patients with tunnel stenosis and a borderline-sized aortic annulus, residual obstruction may develop at the valvar level and need reoperation; the modified Konno operation can, however, delay aortic valve replacement.