Left Ventricular Reshaping Research Articles

Percutaneous transcatheter treatment of hypertension and heart failure: results of the SICI-GISE national survey promoted by the GISE Young Committee

During the last decade, thanks to contemporary evidence and technological improvements, the role of interventional cardiology in the field of cardiac conditions that are mainly treated conservatively has grown a lot. In such scenario, drug-resistant arterial hypertension and heart failure (HF) have a significant role, considering the huge number of involved patients and their impact on mortality and quality of life. This survey was jointly performed by the GISE Young Committee with the support of the SICI-GISE Society and the ICOT group with the aim of evaluating the view of the cardiology community on interventional therapies for arterial hypertension and HF. A web-based questionnaire based on 22 questions was distributed online to SICI-GISE members. The survey was distributed to 1550 physicians with 156 (10%) responses, 58% of whom was under 35 years of age. Renal denervation was available in 49% of Centers, its principal indication was the evidence of severe adverse reactions to anti-hypertensive drugs (80%). Most participants agreed that, compared to past years, there is more understanding of anatomical characteristics and improvement of devices, thus increasing procedural safety; however, main limitations were: appropriate patients' selection criteria (45%), lack of robust evidence (41%) and regulatory (36%) and economical (33%) factors. In the field of HF, this survey enlightened a wide availability of conventional therapies (i.e. mechanical circulatory support, defibrillators, resynchronization) in Italy; on the other side, there is limited availability of innovative devices (i.e. atrial decompression systems, transcatheter left ventricular reshaping). Many participants expressed enthusiastic attitude in this new field, with a look for the need of further evidence in terms of safety and efficacy. Finally, in the treatment of both acute and chronic HF, many participants expressed a problem of limited patient access to advanced therapies, mainly associated with suboptimal networking among institutions. Device-based therapies for arterial hypertension and HF represent a promising option for selected patients; this survey highlights the importance of achieving good quality evidence in both fields, with the goal of proper identification of defined criteria for patients' selection and improvement of procedural and long-term safety and efficacy.

Abstract 15663: Trasapical Mitral Valve and Left Ventricular Reshaping to Repair Functional Mitral Regurgitation in a Dilated Ventricle

Background: The COAPT trial demonstrated that repair of functional mitral regurgitation (FMR) in heart failure (HF) improves prognosis, only when the LV end diastolic diameter is <65mm. A significant need exists for a new therapy that can address both FMR and the LV in patients with LV EDD>65mm. In this study, we report a novel beating heart transapical device that can address FMR by beating heart papillary muscle approximation (PMA), and reduces the LV size and sphericity as well. Preclinical efficacy of this novel device in a swine HF/FMR model is reported. Methods: The device was prototyped using biocompatible 3D printed parts (Fig A), and a delivery catheter was custom designed for beating heart deployment (Fig B). In 7 healthy pigs, and 4 pigs induced with chronic post-myocardial infarction HF, with moderate or greater FMR, the device was implanted via a transapical access. The device was adjusted in steps - (step 1) reduce the inter-PM distance to an extent that FMR is mild or less; and (step 2) reshape the LV to achieve a 30% reduction in LV EDV and 25% reduction in sphericity index (SI). Echocardiography was used to assess mitral valve function and LV geometry, and LV function was assessed with invasive hemodynamics. Pigs were survived thereafter. Results: With this new device, MR was consistently reduced from moderate levels to none/mild. Mitral valve coaptation length increased from 3.49 ± 0.42 to 6.45± 1.13 mm (p=.019) and tenting area decreased from 158.09± 33 to 116.4± 16.7mm 2 (p=.05). LV EDV was reduced from 142.8± 29.6 to 97.5± 19.6ml (p=.025), SI was decreased from 0.67± 0.04 to 0.49± 0.07 (p=.0497) and IPMD was reduced from 23.5± 5.7 to 12.76± 3.0mm (p=.032). The device did not adversely impact cardiac output (6.59± 1.3 to 4.83± 1.6 LPM, p=.067) or E/A wave ratio (1.40± 0.23 to 1.35±0.29, p=.60). Conclusion: This novel transapical beating heart MV and LV reshaping device, significantly reduced FMR and reshaped the LV in this swine model.

Hybrid transcatheter left ventricular reconstruction for the treatment of ischemic cardiomyopathy.

Left ventricular (LV) enlargement is a mechanical adaptation to accommodate LV systolic inefficiency following an acute damage or a progressive functional deterioration, which fails to correct the decline of stroke volume in the long term, leading to progressive heart failure (HF). Surgical ventricular reconstruction (SVR) is a treatment for patients with severe ischemic HF aiming to restore LV efficiency by volume reduction and LV re-shaping. Recently, a new minimally-invasive hybrid technique for ventricular reconstruction has been developed by means of the Revivent™ system (BioVentrix Inc., San Ramon, CA, USA). The device for ventricular reconstruction consists of anchor pairs that enable plication of the anterior and free wall LV scar against the right ventricular (RV) septal scar of anteroseptal infarctions to decrease cardiac volume without ventriculotomy in a beating-heart minimally-invasive procedure, consisting of a transjugular and left thoracotomy approach. Patients with severe (Grade 4) functional mitral regurgitation (FMR) or with previous cardiac surgery procedures were excluded. Outcome of the reconstruction procedure: from 2012 until 2019, it has been applied to 203 patients, with 5 (2.5%) in-hospital deaths. LV volume reduction varied according to experience gained along years: LV end-systolic volume index decreased from baseline 43% (post-market registry) vs. 27% (CE-mark study); left ventricular ejection fraction (LVEF) increased from baseline 25% (post-market registry) vs. 16% (CE-mark study). Clinical status (NYHA class, HF questionnaire, 6-minute walking test) improved significantly compared to baseline, and re-hospitalization rate was only 13% at 6-month follow-up (60% of patients in NYHA =3). FMR grade decreased at follow-up in 63%, while it was unchanged in 37% of patients. The hybrid ventricular reconstruction (HVR) seems a promising treatment for HF patients who may benefit from LV volume reduction, with reasonable mortality and good results at follow-up. A baseline less severe clinical profile was not associated to better outcome at follow-up, which makes the procedure feasible in patients with very large ventricles and depressed ejection fraction (EF). LV reshaping has no detrimental effect on FMR, that may, on the contrary, benefit owing to less papillary muscle displacement, partial recovery of torsion dynamics and of myofibers re-orientation. A controlled study on top of optimal medical treatment is warranted to confirm its role in the management of HF patients.

LIVE procedure for ischemic heart failure: the evolution of an unique technique

Abstract Background Ischemic cardiomyopathy is the leading cause of heart failure. In patients with left ventricular (LV) dilatation, low ejection fraction, and transmural scar in an anteroseptal distribution, surgical ventricular reconstruction (SVR) is a treatment option. However, SVR is an invasive procedure which often cannot be offered to patients with ischemic cardiomyopathy due to other comorbidities. Less Invasive Ventricular Enhancement (LIVE) technique is a unique intervention to exclude scarred myocardium, improving symptoms and quality of life. Methods LIVE procedure has evolved from open sternotomy to a hybrid procedure done with right internal jugular vein access and a left minithoracotomy. LV shape and size is restored without extracorporeal circulation by plication of the scarred myocardium. This is achieved by implantation of a series of internal and external microanchors brought together over a poly-ether-ether-ketone (PEEK) tether to make a longitudinal approximation between the LV free wall and the anterior septum. Internal anchors are deployed by a transcatheter technique, through the right internal jugular vein, on the right side of the ventricular septum. Results Between July 2018 and January 2020, 47 patients (84.4% men; mean age 61±12.5 years) were submitted to the LIVE procedure in 16 Institutions in Europe, North America and Asia. Procedural success was 100%. There was no intra-hospital mortality. A mean of 2.3 anchor pairs (median 2) were used to reshape the LV. Echocardiographic data showed an increase in LV ejection fraction (EF) from 31.4±9.2% to 40.0±12.4% (change +29.8%, p<0.001) and LV end-systolic volume index (LVESVI) reduction from 66.6±29.3 ml/m2 to 40.7±21.5 ml/m2 (change −38%, p<0.001) and LV end-diastolic volume index (LVEDVI) reduction from 92.8±39.2 ml/m2 to 60.6±25.9 ml/m2 (change −33.2%, p=0.001) after the procedure. Sternotomy conversion was needed in one patient due to right ventricular perforation. New onset tricuspid valve regurgitation was observed in one patient. There was no case of ventricular septal defect. In the mean follow-up period of 9.8 months, NYHA class improved a median of 1 grade and there was no late mortality. Conclusion Hybrid LV reshaping and volume reduction has proven to be a useful option for patients with symptomatic heart failure after left anterior descending territory myocardial infarction. These results from the latest iteration of the technique show that this approach is safe and has a significant short and mid-term impact on improving EF and reduction in LV. LIVE procedure Funding Acknowledgement Type of funding source: None

Devices for Mitral Valve Repair

The natural history of severe mitral regurgitation (MR) is unfavorable, leading to left ventricular failure, atrial fibrillation, stroke, and death. Many patients affected by severe regurgitation (MR) do not currently undergo surgery, mainly due to the perceived risk of the procedure (old age, impaired left ventricular function, and comorbidities). Mitral transcatheter interventions carry the hope of minimizing risks while preserving clinical efficacy of surgical repair, as an alternative to conventional treatment. Multiple technologies and diversified approaches are under development with the purpose of treating MR in less invasive ways. They can be categorized based on the anatomical and patho-physiological addressed target. Among them, MitraClip (Abbott Vascular, Inc., Menlo Park, California) has emerged as a clinically safe and effective method for percutaneous mitral valve repair in patients either with degenerative and functional regurgitation. This device mimics the surgical edge-to-edge repair initially described by Alfieri in the early 1990s. Other repair technologies include percutaneous direct and indirect annuloplasty, neochordae implantation, and left ventricular reshaping. They are still in early phase clinical trials or preclinical studies. The combination of different repair techniques is likely to be required to achieve good long-lasting results. In the future, novel devices, improved knowledge, more efficient imaging, and transcatheter mitral prosthetic valve implantation may expand the indications to those patients currently not treated, as well as improve the results both in terms of early efficacy and long-term durability. These treatments are currently reserved to high-risk and inoperable patients, and their application requires an integrated Heart-Team approach. They represent the natural evolution of surgery and promise to expand treatment options and improve patients' outcomes in the near future.

Recent Advances and Patents on Novel Devices for Minimally Invasive Treatment of Functional Mitral Regurgitation

There are a variety of novel patented devices available to treat functional mitral regurgitation. Aside from direct valve replacement or repair, devices that can be implanted through a minimally invasive approach tend to amend this disease via one of three techniques: edge-to-edge repair, annuloplasty, or left ventricular reshaping. Recent attention has been allocated towards development of prospective devices to enable percutaneous mitral valve replacement. Clinical implementation of these devices is contingent upon evidence to suggest that they meet safety and efficacy requirements. This review provides a brief description of patents relevant to some commercial devices that are currently undergoing clinical trials and other devices that are still under pre-clinical testing. Keywords: Functional mitral regurgitation, mitral valve, mitral annulus, minimally invasive, cardiac devices, percutaneous, off-pump, LV dilation

Comparison of Coapsys annuloplasty and internal reduction mitral annuloplasty in the randomized treatment of functional ischemic mitral regurgitation: Impact on the left ventricle

Functional mitral regurgitation is associated with both annular and ventricular distortion. Aggressive reduction annuloplasty for functional mitral regurgitation acts primarily at the annulus, with variable impact on the left ventricle. The Coapsys device externally reshapes the left ventricle to correct functional mitral regurgitation. Left ventricular reshaping was analyzed in a randomized study. The RESTOR-MV study randomizes patients with coronary artery disease and functional mitral regurgitation to either reduction annuloplasty and coronary artery bypass grafting (the RA group) or Coapsys annuloplasty and bypass grafting (the CO group). The Coapsys device consists of epicardial pads connected by a cord. It was placed without cardiopulmonary bypass under echocardiographic guidance and sized to reduce annular dimension and improve leaflet coaptation. Internal reduction annuloplasty was performed by device placement. Intraoperative transesophageal echocardiograms were analyzed in 7 patients having reduction annuloplasty and 7 having Coapsys annuloplasty. Baseline mitral regurgitation (0-4 scale) was similar for the RA (3.0 +/- 0.6) and the CO groups (3.0 +/- 0.6). Intraoperative mitral regurgitation was reduced from 2.86 +/- 0.7 to 0.5 +/- 0.7 (P < .01 pre vs post) for the RA group and from 2.64 +/- 0.9 to 05 +/- 0.7 (P < .01 pre vs post) for the CO group. Annular anteroposterior diameter was reduced with both techniques: RA, 3.45 +/- 0.39 to 2.34 +/- 0.37 cm (P < .01 pre vs post); CO, 3.40 +/- 0.27 to 2.85 +/- 0.34 cm (P < .05 pre vs post). Long-axis dimensions were unchanged with both techniques. Short-axis dimensions measured at three levels were significantly reduced only in the CO patients: basal diameter 4.77 +/- 0.58 to 3.58 +/- 0.38 cm (P < .01 pre vs post); mid diameter 4.88 +/- 0.55 to 3.57 +/- 0.43 cm (P < .01 pre vs post); and apical diameter 4.39 +/- 0.46 to 3.38 +/- 0.34 cm (P < .01 pre vs post). Coapsys and reduction annuloplasty techniques both acutely reduce functional mitral regurgitation and annular dimension. The Coapsys device provided significantly greater left ventricular reshaping than did reduction annuloplasty. Further evaluation will assess the long-term valvular function and ventricular geometric stability associated with both techniques.

Longitudinal Isovolumic Displacement of the Left Ventricular Myocardium Assessed by Tissue Velocity Echocardiography in Healthy Individuals

Rapid myocardial isovolumic motions are reportedly involved in the left ventricular reshaping process and may contribute to total systolic myocardial shortening. In this study, the qualitative and quantitative analysis of longitudinal myocardial isovolumic displacement was performed in 49 healthy individuals (23 men and 26 women) in age groups 21 to 49 and 50 to 76 years using tissue velocity echocardiography. The obtained isovolumic contraction and relaxation displacement curves were biphasic and displayed a significant regional heterogeneity most probably reflecting active presystolic and postsystolic reshaping of left ventricular cavity. Besides some sex difference in younger individuals, there was an age-dependent lengthening of the isovolumic relaxation time and their motion components. Even if being of short duration, the longitudinal myocardial isovolumic displacement may accounted for as much as 14% of the total longitudinal myocardial shortening, a fact which should be taken into consideration when assessing left ventricular systolic function.

Effectively treating ischemic mitral regurgitation with chordal cutting in combination with ring annuloplasty and left ventricular reshaping approach

Effectively treating ischemic mitral regurgitation with chordal cutting in combination with ring annuloplasty and left ventricular reshaping approach

Early and late results of left ventricular reshaping by passive cardiac-support device in canine heart failure

Background: We tested whether the CardioClasp, a passive non–blood-contacting device could decrease excessive geometric burden in dilated cardiomyopathy and improve left ventricular systolic function and contractility by reshaping the left ventricle (LV) and by decreasing LV wall stress (LVWS) without decreasing arterial blood pressure. Methods: In mongrel dogs ( n = 6, the early group; n = 6, the chronic group; 25–27 kg), 4 weeks of rapid right ventricular pacing (210 to 240 bpm) induced dilated cardiomyopathy with heart failure. In the early group, we used hemodynamic data and echocardiography to evaluate LV systolic function immediately after placing the CardioClasp device. In the chronic group, we also evaluated LV systolic function immediately after placing the device on dilated hearts and then left the device in place for 30 days. At the end of 30 days, before explantation of the device, we again assessed LV systolic function. We measured fractional area of contraction (FAC), LVWS, and hemodynamic data in both groups. Results: In the early group, use of the CardioClasp device decreased the LV end-diastolic anterior-to-posterior dimension by 27.8% ± 2.6% at implantation ( p < 0.05). In the chronic group, use of the CardioClasp decreased the LV end-diastolic anterior-to-posterior dimension by 19.4% ± 2.0% at implantation ( p < 0.05) and by 22.0% ± 3.10% at explantation ( p < 0.05). Use of the CardioClasp did not alter LV end-diastolic and peak pressure, LV dP/dts, or cardiac output at implantation or at explantation. In the early group, use of the CardioClasp decreased the LVWS by 43.4% ± 3.1% at implantation ( p < 0.05). In the chronic group, LVWS decreased by 28.8% ± 2.1% at implantation ( p < 0.05) and by 43.3% ± 5.2% at explantation ( p < 0.05). In the early group, FAC increased significantly, by 28.9% ± 7.8% at implantation ( p < 0.05). In the chronic group, FAC increased significantly, by 18% ± 12% at implantation ( p < 0.05) and by 19% ± 12% at explantation ( p < 0.05). Conclusions: As expected, use of the CardioClasp device increased FAC and decreased LVWS by reshaping the LV. Use of the CardioClasp device maintained cardiac output and arterial pressure. In 30-day experiments, the increased FAC and decreased LVWS were maintained at explantation.

Left ventricular systolic performance in failing heart improved acutely by left ventricular reshaping

Objective If the geometric distortion during dilated heart failure could be corrected, the tension on the myocytes would be decreased, thereby leading to an improvement in left ventricular systolic function. We tested the effects of the CardioClasp (CardioClasp Inc, Pine Brook, NJ), a left ventricular reshaping device, on the failing heart, and our empirical data were compared with computationally derived data. Methods Heart failure was induced by 4-week rapid cardiac pacing. At the terminal experiment, an isolated failing heart preparation (isovolumic contraction, n = 5) or an intact failing heart in vivo (n = 7) was used. The effects of the reshaping device on left ventricular performance were assessed by the slopes (Ees) of the left ventricular end-systolic pressure-volume relations, hemodynamics, and echocardiograph before and after placing the CardioClasp on the heart. The change in Ees as the result of left ventricular reshaping was also estimated from computed theoretical analysis and compared with empirical data. Results There was a significant change in left ventricular dimension after placing the CardioClasp on the heart. In isolated heart preparation, Ees significantly increased from 1.40 ± 0.44 mm Hg/mL to 2.42 ± 0.63 mm Hg/mL after placing the device on the heart but returned to the baseline level (1.46 ± 0.27 mm Hg) after removing it. Left ventricular developed pressure and left ventricular fractional area shortening were significantly increased as the result of left ventricular reshaping. Ees derived from computed theoretical analysis was highly correlated with confirming empirical data. Conclusions The CardioClasp can reshape the left ventricle and improve left ventricular systolic performance in failing hearts. 17,22

Left ventricular reshaping: Effects on the pressure-volume relationship

Objective: We tested whether the CardioClasp device (CardioClasp, Inc, Cincinnati, Ohio), a non-blood contact device, would improve left ventricular contractility by acutely reshaping the left ventricle and reducing left ventricular wall stress. Methods: In dogs (n = 6) 4 weeks of ventricular pacing (210-240 ppm) induced severe heart failure. Left ventricular function was evaluated before and after placement of the CardioClasp device, which uses 2 indenting bars to reshape the left ventricle. Hemodynamics, echocardiography, and Sonometrics crystals dimension (Sonometrics Corporation, London, Ontario, Canada) were measured at steady state and during inferior vena caval occlusion. Results: The CardioClasp device decreased the left ventricular end-diastolic anterior-posterior dimension by 22.8% ± 1.9%, decreased left ventricular wall stress from 97.3 ± 22.8 to 67.2 ± 7.7 g/cm2 (P =.003), and increased the fractional area of contraction from 21.3% ± 10.5% to 31.3% ± 18.1% (P =.002). The clasp did not alter left ventricular end-diastolic pressure, left ventricular pressure, left ventricular dP/dt, or cardiac output. With the CardioClasp device, the slope of the end-systolic pressure-volume relationship was increased from 1.87 ± 0.47 to 3.22 ± 1.55 mm Hg/mL (P =.02), the slope of preload recruitable stroke work versus end-diastolic volume was increased from 28.4 ± 11.0 to 44.1 ± 23.5 mm Hg (P =.02), and the slope of maximum dP/dt versus end-diastolic volume was increased from 10.6 ± 4.6 to 18.6 ± 7.4 mm Hg×s−1×mL−1 (P =.01). The CardioClasp device increased the slope of the end-systolic pressure-volume relationship by 68.0% ± 21.7%, the slope of preload recruitable stroke work versus end-diastolic volume by 50.7% ± 18.1%, and the slope of maximum dP/dt versus end-diastolic volume by 85.7% ± 28.9%. Conclusions: The CardioClasp device decreased left ventricular wall stress and increased the fractional area of contraction by reshaping the left ventricle. The CardioClasp device was able to maintain cardiac output and arterial pressure. The clasp increased global left ventricular contractility by increasing the slope of the end-systolic pressure-volume relationship, the slope of preload recruitable stroke work versus end-diastolic volume, and the slope of maximum dP/dt versus end-diastolic volume. In patients with heart failure, the CardioClasp device might be effective for clinical application.J Thorac Cardiovasc Surg 2002;125:391-9

Left ventricular reshaping by cardioclasp device enhances contractility and improves systolic function in dilated cardiomyopathy

Left ventricular reshaping by cardioclasp device enhances contractility and improves systolic function in dilated cardiomyopathy