Category Archives: Cardiac Surgery

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First patient enrolled in an international multicenter clinical study for non-invasive cardiac resynchronization therapy

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BOLZANO/ BOZEN, Italy, 19-Mar-2023 — /EPR HEALTHCARE NEWS/ — XSpline SPA, a start-up company incorporated in Bolzano (Italy) and the Ordensklinikum Linz Elisabethinen Hospital in Linz (Austria) today announced the first patient enrolled in a clinical study (ClinicalTrials.govID: NCT05327062) for the cardiac resynchronization therapy (CRT) guided by non-invasive electrical and venous anatomy assessment.  The international multicenter prospective study will include 150 patients from 16 centers in the U.S. and Europe.

XSpline Cloud provides a cloud-based non-invasive cardiac panoramic mapping technology to select individual CRT treatment strategy and predict outcomes.

Fast and fully automatic Artificial Intelligence based epi- and endocardial segmentation of cardiac structures, including coronary sinus veins, provides clear understanding of individual patient’s anatomy. The electrical assessment is based on a 3D panoramic electro-anatomical map based on 12 -lead ECG only, without requiring multichannel ECG recording or any kind of body surface potential mapping. XSpline Cloud is the first system in the world with AI based identification of the correct target zone for LV lead implantation.

The cloud-platform guarantees full operability with existing clinical standards and data formats; it supports IHE profiles, HL7 FIHR, DICOM, and a broad range of ECG formats. The platform also provides embedded medical grade visualization tools, such as an integrated multimodality DICOM viewer, an ECG viewer with measurement capabilities, a high-performance 3D viewer for segmented cardiac structures and electro- anatomical maps as well as an interactive navigator for LV lead placement.

Dr. Georgios Kollias, M.D., is the principal investigator for the clinical trial in Austria and performed the first procedure on a 71-year-old patient with ESV LV of 154 ml and EF LV of 20%.

“The XSpline Cloud software provides a unique approach to selecting an individualized CRT treatment strategy. It is a comprehensive tool for successful CRT implantation that can also predict outcomes, making the implantation procedure faster, easier, and safer for the patient. We are very pleased to start using this tool in our clinic”, said Dr. Kollias.

“XSpline SPA is supported by an international R&D team of skilled clinicians, mathematicians, and biomedical engineers with the shared goal of improving patient care. We think that the real-time visualization of each patient’s individual anatomy, the precise non-invasive electro-anatomical endo- and epicardial activation map and the interactive navigator will help to increase CRT responders”, said Mr. Werner Rainer, CEO of the company.

XSpline Cloud is an investigational device and not yet approved for commercial use.

SOURCE: EuropaWire

Cardiac Surgery, Cardiology, Child health, Critical Care, Healthcare, Healthcare Professionals, Healthcare Services, Physicians, Society

“Heart Within a Heart” – Surgery Cures 12 Year Old With Rare Congenital Heart Disease

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A 12 year old Indian boy successfully underwent open heart surgery for an extremely rare variant of Total Anomalous Pulmonary Venous Connection (TAPVC) at Sri Muthukumaran Medical College and Research Institute, Mangadu, Chennai.

Prabhakaran, a ‘blue baby’ born with a heart birth defect seen in only 1 out of every 500,000 births, had 2 “hearts” inside his chest, one within the other. This complexcongenital heart disease is so rare that it merited selection out of 430+ submissions to be presented at the recently concluded international conference of the Indian Association of Cardiothoracic Surgery (IACTS) at Mumbai in February 2013.

In an intricate open heart operation that lasted 5 hours, the cardiothoracic surgical team including Dr.S.Sivasubramanian, Dr.S.Visvakumar and Dr.Meenakshisundaram successfully repaired the defect.

Unable to afford the high cost of treatment, Prabhakaran’s widowed mother searched desperately for assistance with her son’s surgery. His operation was sponsored by theDr.Mani Children Heart Foundation, a Chennai-based NGO which has funded 100 heart surgeries for under-privileged children with congenital heart disease since its inception in 2003.

In the defect, a rare intracardiac sub-type of TAPVC, all 4 veins returning oxygen-rich blood from the lungs drained into a common chamber (the “pulmonary confluence”) – forming a mini-heart behind the regular heart.

This mini-heart then pumped blood into the atrium through a hole in the heart called an Atrial Septal Defect (ASD), making him a cyanotic ‘blue baby’. Prabhakaran’s surgery was carried out on 16th October 2012. A week later he was discharged from hospital, his lips and fingernails now pink and healthy.

The department of cardiothoracic surgery and cardiology at Sri Muthukumaran Medical College and Research Institute, Mangadu, Chennai has successfully carried out more than 75 operations on patients with valve, coronary and congenital heart diseases in the short period since its inception.

Congenital heart disease (CHD) is rare, with an estimated incidence of 7 to 8 in 1,000 live births. Surgery is often risky and expensive, yet serious complications can arise if treatment is delayed.

For more information about congenital heart defects (CHD), visit the Dr.Mani Children Heart Foundation website at http://www.CHDinfo.com

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Clinical Trial Studies New Treatment For High-Risk Heart Patients

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A clinical trial under way at the East Carolina Heart Institute is testing the benefit of a new medical device designed to help high-risk people suffering from leaky heart valves.

Dr. W. Randolph Chitwood Jr., director of the Heart Institute and professor of cardiovascular surgery at the Brody School of Medicine at East Carolina University, secured the clinical trial for the MitraClip System for the treatment of mitral valve regurgitation (MR). A serious heart condition, MR can lead to arrhythmias and congestive heart failure if left untreated.

Dr. Curtis Anderson, a cardiothoracic surgeon and assistant professor of cardiovascular sciences, and Dr. Ramesh Daggubati, a cardiologist and clinical professor at Brody, collaborated to perform mitral valve repairs on two patients at Pitt County Memorial Hospital without making the traditional incision in the center of the chest to access the heart. Chitwood joined Drs. Rajasekhar Nekkanti and John Cahill, ECU cardiologists, to assist in the procedure.

In each case, the multidisciplinary team of cardiologists and surgeons placed a thin catheter in the patient’s groin vessel, guided a tiny clip through the heart’s septum and placed the clip between the leaflets of the valve to stop the leak.

“With mitral insufficiency, we normally use the heart/lung machine to either repair or replace the valve,” Chitwood said. “This new procedure is catheter-based, and can be used in high-risk patients who wouldn’t do well on the heart/lung machine. These patients have severe symptoms stemming from the leaky valve and can’t be operated on safely any other way.”

Chitwood said this new procedure “gives the East Carolina Heart Institute an entirely new set of tools for mitral valve repairs in high-risk patients. It is the least invasive way that we can fix a valve. Centers selected to perform these procedures have demonstrated expertise in applying new medical technology under FDA (Food and Drug Administration) guidelines.”

With the clip, patients leave the hospital the next day and within two or three days return to normal activities – or, in many cases, better-than-normal activities.

“Most of the patients are very sick,” said Daggubati, a clinical associate professor of cardiovascular sciences. “Medical management is the only option for them because surgeons consider the risk too high and the patients inoperable.”

Anderson said patient selection is the key to a successful outcome.

“I think a lot of patients with heart failure will be attractive candidates for this device,” he said, adding that collaboration among physicians is vital. “We want patients to have the confidence of knowing that cardiologists and cardiac surgeons are working side by side to give them the best possible outcomes.”

The mitral valve is a one-way valve that connects the left atrium to the left ventricle of the heart. With mitral valve regurgitation, the valve does not seal completely, and blood leaks back into the left atrium. This reversed flow can cause heart and lung damage, as well as death. Symptoms may include an audible heart murmur, shortness of breath and heart palpitations.

About the East Carolina Heart Institute
The East Carolina Heart Institute is a unique partnership that includes University Health Systems Pitt County Memorial Hospital and East Carolina University, along with cardiovascular experts in private practice, academic medicine and research. The East Carolina Heart Institute is the first in North Carolina devoted exclusively to education, research, treatment and prevention of cardiovascular diseases.

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Officials From East Carolina University And University Health Systems Of Eastern Carolina Dedicated The East Carolina Heart Institute Today

Officials from East Carolina University and University Health Systems of Eastern Carolina dedicated the East Carolina Heart Institute today. Several hundred invited guests joined leaders from the two organizations to celebrate the facility. The Heart Institute puts ECU and Pitt County Memorial Hospital “at the forefront of progress and the cutting edge of the future,” said Dr. W. Randolph Chitwood, director of the East Carolina Heart Institute.

“What we dedicate today is a concept called the East Carolina Heart Institute that encompasses these new facilities, dedicated to the people of this region, and to the physicians, researchers, educators and staff devoted to their care,” said Chitwood, who is cardiothoracic surgery and vascular surgery at the Brody School of Medicine at ECU. He is also senior associate vice chancellor for health sciences at ECU.

The dedication ceremony, held at the East Carolina Heart Institute at ECU, capped more than four years of work to bring a world-class cardiovascular disease institute to eastern North Carolina. In 2004, the General Assembly approved $60 million for a research, education and outpatient care facility at ECU. Pitt County Memorial Hospital secured private funding for a $160 million bed tower. Today, leaders from the two organizations celebrated the end of construction on both facilities.

Many who attended the ceremony also toured the two facilities after the event ended. The crowd included local and state officials, donors and other friends of each organization.

The celebration marked “the most significant collaboration University Health Systems and East Carolina University have ever undertaken,” said UHS CEO Dave McRae. “It’s the biggest step of a journey we started more than 30 years ago, when a small county hospital and a fledgling medical school committed to forming the world-class academic medical center we’re part of today,” McRae said.

ECU and PCMH have been “joined at the hip” for decades, ECU Chancellor Steve Ballard said. “The East Carolina Heart Institute is the latest partnership between us, and it will make a major and lasting impact in eastern North Carolina, the entire state and beyond,” Ballard said.

The new buildings aren’t the only sign of a new approach to heart disease for ECU and PCMH. The two organizations have also redefined their model for treating cardiovascular illnesses. Both have organized their clinical staffs around illnesses and disease processes, rather than following a traditional model based on academic specialties. That new model encourages more information-sharing among doctors and puts new emphasis on patients’ best interests, Chitwood said. “This new model of care delivery is an innovative way to blend the science and art of medicine so that we add value to the patient,” Chitwood said.

The prevalence of cardiovascular disease in North Carolina justifies the massive investment in treating and researching heart and vascular illnesses. Cardiovascular disease is the second-leading cause of death in the state, and nearly a quarter of N.C. residents suffer from cardiovascular ailments.

Planning for the East Carolina Heart Institute dates to early 2003. ECU and PCMH held a groundbreaking for the Heart Institute in March 2006. In addition to the six-story 375,000-square-foot bed tower, the Heart Institute at Pitt County Memorial Hospitalspawned a pair of companion projects: construction of a massive central utility plant to power the new building and the relocation of Moye Boulevard.

The Heart Institute at Pitt County Memorial Hospital has 120 cardiovascular beds, six operating rooms, seven interventional laboratories, three electrophysiology labs and a heart-healthy cafeteria, all designed to create the optimal patient care environment.

The four-story, 206,000-square-foot East Carolina Heart Institute at ECU houses science and clinical research, robotic-surgery training, future space for simulation laboratories, a clinical outpatient facility for cardiovascular diseases, a database center, offices and an auditorium.

The Heart Institute at Pitt County Memorial Hospital will open Jan. 5. ECU physicians have been seeing patients at the East Carolina Heart Institute at ECU since September. For more information please visit www.eastcarolinaheartinstitute.com

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