Early results of a real-world series with two transapical transcatheter mitral valve replacement devices.

AIMS: Transcatheter mitral valve replacement (TMVR) with dedicated devices promises to fill the treatment gap between open-heart surgery and edge-to-edge repair for patients with severe mitral regurgitation (MR). We herein present a single-centre experience of a TMVR series with two transapical devices. METHODS AND RESULTS: A total of 11 patients were treated with the Tendyne™ (N = 7) or the Tiara™ TMVR systems (N = 4) from 2016 to 2020 either as compassionate-use procedures or as commercial implants. Clinical and echocardiographic data were collected at baseline, discharge and follow-up and are presented in accordance with the Mitral Valve Academic Research Consortium (MVARC) definitions. The study cohort [age 77 years (73, 84); 27.3% male] presented with primary (N = 4), secondary (N = 5) or mixed (N = 2) MR etiology. Patients were symptomatic (all NYHA III/IV) and at high surgical risk [logEuroSCORE II 8.1% (4.0, 17.4)]. Rates of impaired RV function (72.7%), severe pulmonary hypertension (27.3%), moderate or severe tricuspid regurgitation (63.6%) and prior aortic valve replacement (63.6%) were high. Severe mitral annulus calcification was present in two patients. Technical success was achieved in all patients. In 90.9% (N = 10) MR was completely eliminated (i.e. no or trace MR). Procedural and 30-day mortality were 0.0%. At follow-up NYHA class was I/II in the majority of patients. Overall mortality after 3 and 6 months was 10.0% and 22.2%. CONCLUSIONS: TMVR was performed successfully in these selected patients with complete elimination of MR in the majority of patients. Short-term mortality was low and most patients experienced persisting functional improvement.

Comparison of Mitral Valve Replacement and Repair for Degenerative Mitral Regurgitation: a Meta-analysis and Implications for Transcatheter Mitral Procedures.

PURPOSE OF REVIEW: Surgical mitral valve repair is considered superior to replacement to treat primary mitral regurgitation. However, the heterogeneity of cohorts and the lack of consideration of confounding in the published literature raise potential biases. The aim of this study was to pool all available matched data comparing outcomes of mitral valve repair and replacement in the setting of primary mitral regurgitation. RECENT FINDINGS: We searched Medline, Embase and the Cochrane Library Central Register of Controlled Trials to identify propensity-matched studies or reports with multivariable adjustment comparing repair and replacement in patients with primary mitral regurgitation. The primary outcome was all-cause mortality. DerSimonian and Laird random effects were used to perform the meta-analysis. Eight observational studies were selected including 4599 patients (3064 mitral repairs and 1535 replacements). Mean age ranged from 62 to 69 years, and the mean follow-up duration ranged between 3 and 9 years. Replacement was associated with an increased risk of long-term all-cause mortality compared to repair (HR of 1.68, 95% confidence interval 1.35-2.09, p < 0.001, τ2 = 0.03). Surgical era and atrial fibrillation impacted the risk of mortality but not mitral anatomy. Neither repair nor replacement impacted significantly on the risk of re-operation after mitral surgery (HR 1.18, 95% CI 0.85-1.63, p = 0.33, τ2 < 0.01). Mitral valve replacement is possibly associated with higher long-term mortality than mitral valve repair in primary mitral regurgitation but often used as a bailout option in more complex anatomy. Despite this observation, both techniques have similar risk of re-operation.

Safety and efficacy of the percutaneous transaxillary access for transcatheter aortic valve implantation using various transcatheter heart valves in 100 consecutive patients.

OBJECTIVES: Transcatheter Aortic Valve Implantation (TAVI) can be performed via the transaxillary approach, but data about complications and procedural outcome is limited. INTRODUCTION: TAVI is an established treatment option for patients at high risk for conventional aortic valve replacement. Nowadays, the transfemoral approach is the most commonly used access for TAVI. Nevertheless, the transfemoral access is not suitable in many patients necessitating alternative approaches. METHODS: We analyzed the outcome of 100 consecutive cases receiving percutaneous transaxillary TAVI at two different hospitals. Data were retrospectively analyzed by means of procedural, hemodynamic and clinical outcome. In addition, 1st versus 2nd generation devices were analyzed. RESULTS: Mean age was 78.2±2.1years and the logEuroSCORE I was 24.6±13.9%. Transaxillary TAVI was performed in 85% via the left and in 15% via the right axillary artery. Device success was achieved in 95%. In general, there was a clear learning curve with this approach. No patient experienced a major and 11% a minor access site complication. There was one procedural death (annular rupture) and one peri-procedural TIA. 23% of the patients received a new pacemaker. At discharge, effective orifice area was 1.94±0.16cm2 and the mean aortic gradient was 6.8±2.1mmHg. Moderate aortic regurgitation/paravalvular leakage was documented in two patients. Mortality rates at 30days and one year were 6% and 14.8%. Last but not least, 2nd generation devices showed improved procedural outcomes. CONCLUSIONS: The percutaneous transaxillary access for TAVI is technically feasible and safe thereby yielding excellent clinical results. CONDENSED ABSTRACT: We investigated In 100 consecutive patients undergoing percutaneous transaxillary transcatheter aortic valve implantation thereby demonstrating that this approach is technically feasible and safe with acceptable numbers of minor vascular complications.

[Lymph node metastases in ypT1/2 rectal cancer after neoadjuvant chemoradiotherapy : The Achilles heel of organ-preserving operative procedures?]. / Lymphknotenmetastasen beim ypT1/2-Rektumkarzinom nach neoadjuvanter Radiochemotherapie : Die Achillesferse organerhaltender Operationsverfahren?

BACKGROUND: For patients with rectal cancer and complete remission (ypT0) or with good response and residual tumor restricted only to the bowel wall (ypT1-2) after neoadjuvant chemoradiotherapy (CRT), local excision has been suggested as an alternative to avoid the significant morbidity and functional deficits associated with total mesorectal excision (TME). The aim of this investigation was to investigate the incidence, distribution and tumor-related localization of mesorectal lymph node (LN) metastases in TME specimens with complete remission (ypT0), intramural (ypT1-2) and extramural (ypT3-4) residual tumor tissue. PATIENTS AND METHODS: Specimens of TME from 81 patients with locally advanced rectal cancer (UICC II-III) undergoing neoadjuvant CRT within the phase III German rectal cancer trial CAO/ARO/AIO-04 were prospectively evaluated. The entire mesorectal compartment was microscopically screened after complete paraffin embedding. The number and localization of all detectable LN metastases were documented in relation to the primary tumor. RESULTS: Whereas 50 patients (62 %) had ypT3-4 rectal cancer after neoadjuvant CRT, 20 patients (25 %) presented with residual tumor within the bowel wall (ypT1-2), 11 patients (14 %) had pathological complete remission (ypT0), an average of 28 ± 13.7 LN were detected per specimen and 25 patients (31 %) had residual LN metastases after CRT. Although the incidence of LN metastases was higher in the ypT3-4 group (40 %), 25 % of patients in the ypT1-2 group with intramural residual tumor had a mean number of 2.2 residual LN metastases of which 55 % were located far from the primary lesion in the proximal mesorectum. None of the patients with ypT0 status (complete response) had residual LN metastases. CONCLUSION: Even in patients with good response and post-CRT tumor tissue restricted only to the bowel wall (ypT1-2), there is still a considerable risk for residual LN metastases. Local excision of residual rectal cancer was accompanied by a higher rate of local failure and radical surgery with TME should remain the standard treatment in these patients. To date, valid selection criteria for patients eligible for organ-sparing surgery are still lacking.

Symetis ACURATE TAVI: review of the technology, developments and current data with this self-expanding transcatheter heart valve.

The Symetis ACURATE TA and ACURATE neo technology is a novel transcatheter heart valve for treatment of aortic valvular stenosis. This review illustrates the implantation steps, which are designed for an easy and intuitive transapical and transfemoral TAVI procedure. The most important difference to other self-expanding platforms is the top-down deployment with minimal protrusion of the stent towards the left ventricular outflow tract. In addition, the supra-annularly placed porcine leaflets provide very low gradients and the pericardial skirt acts very effectively to seal against paravalvular leaks. This review reports about the hemodynamic features, low rates of paravalvular leaks and very low rates of pacemaker implantation, which have been observed in various registries. Meanwhile more than 3000 patients have been treated worldwide and additional registries are currently under investigation.

Discrepancies between medical oncologists and surgeons in assessment of resectability and indication for chemotherapy in patients with colorectal liver metastases.

BACKGROUND: Multidisciplinary discussion of the treatment of patients with colorectal liver metastases (CRLM) is advocated currently. The aim of this study was to investigate medical oncologists' and surgeons' assessment of resectability and indication for chemotherapy, and the effect of an educational intervention on such assessment. METHODS: Medical histories of 30 patients with CRLM were presented to ten experienced medical oncologists and 11 surgeons at an initial virtual tumour board meeting (TB1). Treatment recommendations were obtained from each participant by voting for standardized answers. Following lectures on the potential of chemotherapy and surgery, assessment was repeated at a second virtual tumour board meeting (TB2), using the same patients and participants. RESULTS: Overall, 630 answers (21 × 30) were obtained per tumour board meeting. At TB1, resectability was expected more frequently by surgeons. Participants changed 56·8 per cent of their individual answers at TB2. Assessment shifted from potentially resectable to resectable CRLM in 81 of 161 and from unresectable to (potentially) resectable CRLM in 29 of 36 answers. Preoperative chemotherapy was indicated more often by medical oncologists, and overall was included in 260 answers (41·3 per cent) at TB1, compared with only 171 answers (27·1 per cent) at TB2. Medical oncologists more often changed their decision to primary resection in resectable patients (P = 0·006). Postoperative chemotherapy was included in 51·9 and 52·4 per cent of all answers at TB1 and TB2 respectively, with no difference in changes between medical oncologists and surgeons (P = 0·980). CONCLUSION: Resectability and indication for preoperative chemotherapy were assessed differently by medical oncologists and surgeons. The educational intervention resulted in more patients deemed resectable by both oncologists and surgeons, and less frequent indication for chemotherapy.

Transcatheter aortic valve implantation: alternative access options.

Calcific aortic valve stenosis represents the most common acquired valvular heart disease in adults. Transcatheter aortic valve implantation (TAVI) has been established as a widely accepted therapeutic option in elderly and multimorbid patients with severe aortic stenosis not amenable to conventional surgery. Retrograde transfemoral and antegrade transapical approaches are commonly used for implantation. However, there are a certain number of patients who are not candidates for either approach due to poor vascular access, severe pulmonary dysfunction or other prohibitive chest pathologies. Recently, different alternative access route options have been proposed and described. These alternative access routes include approaches via the subclavian/axillary artery, the ascending aorta, the carotid artery, and the brachiocephalic artery.

What's new in transapical aortic valve implantation: clinical experience with second generation devices.

Within 10 years after transcatheter aortic valve implantation (TAVI) was first accomplished for treatment of calcified aortic stenosis, this new technology has rapidly evolved to become clinical routine. Today it may be considered standard treatment for inoperable patients with superior outcomes compared to best medical therapy. Furthermore, it represents an alternative therapeutic option compared to surgical aortic valve replacement in high-risk patients. According to current international guidelines and expert consensus statements, TAVI should be performed as a joint effort by an interdisciplinary heart team to ensure input from multiple skill sets for optimal patient outcome. Major safety concerns include neurologic complications, acute kidney injury, access site complications, procedure-related conduction disturbances, paravalvular leakage valve durability. At present, only one device for transapical TAVI is in widespread clinical use: the Edwards Sapien transcatheter valve (Edwards Lifesciences, Irvine, CA, USA). Recently, however, a number of second generation devices for transapical TAVI have been developed in order to address some of the limitations of first generation valves. In this paper, current data on second generation devices for transapical TAVI will be reviewed and ongoing trials discussed.

Metastatic recurrence after complete resection of colorectal liver metastases: impact of surgery and chemotherapy on survival.

PURPOSE: Surgery is the standard of care for resectable colorectal liver metastases (CRC-LM). Unfortunately, 60% of patients develop secondary metastatic recurrence (SMR) after R0-resection of CRC-LM. We investigated the impact of surgical re-intervention and chemotherapy (Ctx) on survival in a consecutive series of patients with SMR. METHODS: From 01/2001 to 11/2011, 104 out of 178 consecutive patients with R0-resection of CRC-LM developed SMR and were evaluated. The impact of surgical and Ctx re-interventions on recurrence free (RFS) and cancer-specific survival (CSS) was analyzed. Median follow-up was 28.0 (95%CI: 19.4-37.4) months. RESULTS: SMR occurred in 81 patients at a single site (49× liver, 18× lung, 14× other) and in 23 patients at multiple sites. Forty-two patients were scheduled for primary surgery. Fifty-three patients were classified as non-resectable and treated with median 5.0 [IQR, 3.0-10.0] cycles of Ctx, combined with an EGFR/VEGF-antibody in 27 patients. Nine patients received best supportive care only. R0/R1 resection could be achieved in 35 patients primarily and even in 8 patients secondarily after Ctx. Surgical morbidity and mortality were 16 and 0%, respectively. The 5-year RFS rates for patients with R0 versus R1-resection were 22 and 24% (p = 0.948). The 5-year CSS rate for R0/R1-resected patients was 38% versus 10% for those patients treated by Ctx alone (p < 0.001). CONCLUSION: In SMR, surgical re-intervention is feasible and safe in a remarkable number of patients and offers significantly longer CSS compared to patients without resection.

Bilobar spreading of colorectal liver metastases does not significantly affect survival after R0 resection in the era of interdisciplinary multimodal treatment.

PURPOSE: Bilobar colorectal liver metastases (CRLM) are often considered incurable or associated with poor prognosis even after R0 resection. In this single-center study, we evaluate the impact of CRLM spreading on recurrence-free survival (RFS) and cancer-specific overall survival (CSS) after R0 resection of CRLM with respect to multimodal treatment strategies including perioperative chemotherapy and multistep resections. METHODS: Between January 2001 and December 2010, R0 resection could be achieved in 70 patients with bilobar and 100 with unilobar CRLM. Extent of disease, perioperative chemotherapy, surgical procedures, adjuvant treatment, histopathological workup, RFS, and CSS were compared between both cohorts. RESULTS: Forty-six (66 %) patients with bilobar and 26 (26 %) patients with unilobar CRLM received preoperative chemotherapy (p < 0.001). For bilobar CRLM, more extended and multistep resection including portal vein occlusion were performed (29 % versus 3 %; p < 0.001). Morbidity (39 % versus 28 %, p = 0.183) and mortality (1 % versus 3 %, p = 0.644) rates were comparable in both patients' cohorts. Postoperative therapy was applied in adjuvant intent to 42 (60 %) versus 51 (51 %) patients (p = 0.275). The 5-year RFS and CSS rates were 24 % versus 31 % (p = 0.169) and 42 % versus 55 % (p = 0.131), respectively. CONCLUSIONS: To our single-center experience, there is no significant effect of CRLM spreading (bilobar versus unilobar) on RFS and CSS rates. Bilobar CRLM are more likely to require extended multimodal efforts to achieve R0 resection.

Simultaneous transcatheter aortic and mitral valve-in-valve implantation in a patient with degenerated bioprostheses and high surgical risk.

Transcatheter valve-in-valve implantation is evolving as a promising alternative to reoperative valve replacement in selected high-risk patients, considering the increasing need for redo surgery due to bioprosthetic degeneration in the future. Reoperative double valve replacements are particularly associated with an elevated surgical risk. The transapical access provides the opportunity to approach the aortic and mitral valves during one intervention. We report the case of a successful transcatheter valve-in-valve implantation in the aortic and mitral position within a single procedure.

[Treating mitral regurgitation: a surgical and interventional update]. / Therapie der Mitralklappeninsuffizienz: Chirurgische und interventionelle Neuerungen.

Surgical mitral valve repair has constantly evolved to become the standard of care for severe mitral regurgitation (MR) with superior acute and long-term results compared to valve replacement. Minimally-invasive surgical techniques have been successful in reducing operative trauma while yielding equivalent or even superior results compared to the conventional sternotomy approach. However, due to elevated operative risk a growing proportion of patients are not referred for surgery, especially elderly patients with reduced ventricular function and functional MR who often present with relevant comorbidities. It is for these patients that transcatheter-based therapies may represent an attractive option. While most interventional techniques are still in experimental or early clinical stages of development, relevant clinical experience has been gained with the MitraClip® device. For successful implementation of a patient-centered mitral valve program, integration of surgical and interventional treatment modalities within a heart center is of paramount importance. This is best accomplished by an interdisciplinary dedicated heart team consisting of cardiologists and cardiac surgeons.

Minimally invasive resection of a right atrial mass in a cardiac transplant recipient: a case report.

Intracardiac thrombus formation usually occurs in the left-sided cavities of the heart, most frequently in the presence of atrial fibrillation or cardiomyopathy. We report the case of an initially unclear mass developing in the right atrium (RA) of a heart transplant recipient, which was subsequently resected via a minimally invasive surgical approach. Access via right anterior minithoracotomy using videoscopic assistance allowed for uncomplicated RA thrombectomy in the presented case, avoiding reentry sternotomy with the potential risk of cardiac injury and without aortic cross-clamping or cardioplegic arrest. The patient is doing fine with excellent graft function at the latest follow-up 4 months after minimally invasive thrombectomy and 30 months after cardiac transplantation. To the best of our knowledge, this is the first report describing minimally invasive resection of a right atrial thrombus in a heart transplant recipient.

Transcatheter aortic valve implantation in a heart transplant recipient: a case report.

Transcatheter aortic valve implantation (TAVI) has evolved into a feasible therapeutic option for the management of selected patients with severe aortic stenosis and high or prohibitive risk for standard surgery. Symptomatic severe aortic stenosis occasionally occurs in the allograft long after heart transplantation. Because of specific characteristics and comorbidities of heart transplant recipients, these patients may be considered candidates for this less invasive approach. We report a first case of successful transapical TAVI in a heart transplant recipient with symptomatic severe calcific aortic valvular disease and relevant comorbidities long after heart transplantation.

Best way to revascularize patients with main stem and three-vessel lesions. Patients should be operated!

Despite established guidelines for the treatment of coronary artery disease (CAD) by either coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI), everyday clinical practice has proven to differ substantially with even the most complex coronary lesions being targeted by PCI today. However, an abundancy of clinical trials, both observational and randomized has proven the superiority of coronary surgery over PCI in almost every type of multivessel or left main CAD in symptomatic patients. This holds true also for 'hard' endpoints like cardiac death or myocardial infarction as recently demonstrated by the landmark SYNTAX trial. These results have lead to the wording of appropriateness criteria, which integrate current guidelines, evidence from clinical trials and interdisciplinary expert opinion and which express essentially the same message as the SYNTAX trial: "CABG remains the standard of care for patients with three-vessel or left main coronary artery disease"